Research using the multidimensional sleep health (MDSH) framework has increased globally, often relying on self-report measures. The Ru-SATED scale and Sleep Health Index (SHI) are common self-report measures of MDSH, but comparative data on their measurement properties and contextual characteristics remain limited. Seven electronic databases were searched for measurement properties and uses of the two scales over the past twelve years. This review identified 19 psychometric validation studies concerning two original and 17 cross-cultural, and summarized contextual comparison of MDSH measures and frameworks. Measurement properties of both measures were assessed with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline, and contextual comparisons were conducted narratively. Both measures exhibited acceptable psychometric properties across diverse cultural settings, with the SHI findings showing greater consistency than those of the Ru-SATED scale. Aggregating the Ru-SATED and SHI frameworks fully covered the sleep characteristics assessed by five instruments grounded in the World Sleep Society initiative, encompassing regularity, satisfaction, alertness, timing, efficiency, duration, and disorder. Notably, the SHI framework incorporates targeted sleep disorder assessment while the Ru-SATED framework specifically excludes such assessment, highlighting the distinct focus and scope of each tool. Instrument selection depends primarily on research purpose, study sample, and intended use. We recommend characterizing both sleep health and sleep disorders to fully capture the complex relationships between sleep and health outcomes.

Background:Sleep disturbances are common and distressing for people with dementia and their family carers and can lead to carers having interrupted sleep, low mood and care breakdown. Medication can have harmful side effects and is generally ineffective. Non-pharmacological interventions should be first-line treatments, yet until now there have not been effective treatments. Objectives:To establish whether Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS START), a multicomponent intervention, reduced sleep disturbance in people with dementia living at home at 8 months compared with National Health Service treatment (treatment as usual). Design and methods:We conducted a two-arm, multicentre, parallel-arm, superiority randomised controlled trial with masked outcome assessment. Participants were randomised (1 : 1 ratio) to DREAMS START intervention plus treatment as usual or treatment as usual alone. Analyses were intention to treat. We conducted a mixed-method process evaluation with additional substudies: one exploring how United Kingdom-based South Asians experience sleep disturbance and dementia, and one exploring the interaction of sleep, dementia and long-term conditions. Settings and participants:We recruited dyads of people with dementia and sleep disturbance living at home and family carers from 12 National Health Service trusts and the Join Dementia Research service in England. Interventions:DREAMS START is a six-session, multicomponent, manualised intervention delivered to family carers of people with dementia who implement strategies to improve their relatives' sleep. It is delivered face to face or remotely by non-clinically trained graduates weekly or fortnightly and incorporates information about sleep and dementia, promotes de-arousal at night, adaptive stimulus control (e.g. bedtime routine maintenance), daytime behavioural activation, increasing access to light, improving carer sleep and making a tailored action plan. Main outcome measures:The primary outcome was sleep disturbance measured using the Sleep Disorders Inventory at 8 months. Results:Between February 2021 and March 2023, 377 dyads were randomly assigned, 189 to treatment as usual and 188 to DREAMS START plus treatment as usual. Mean age of participants with dementia was 79.4 years (standard deviation 9.0), and 206 (55%) were women. Mean Sleep Disorders Inventory score at 8 months was lower in the intervention versus treatment-as-usual arm [15.16 (standard deviation 12.77), n = 159, vs. 20.34 (16.67), n = 163]; adjusted difference in means [-4.70 (95% confidence interval -7.65 to -1.74); p = 0.002]. Seventeen (9%) people with dementia in the intervention and 17 (9%) in the control arm died during the trial; deaths were unrelated to the intervention. The mean incremental difference in health and care costs incorporating wider costs was £116 less per dyad (95% confidence interval -£5769 to £5536) for DREAMS START compared to treatment as usual. There was a 78% probability that DREAMS START is cost-effective compared to treatment as usual at a £20,000 decision threshold with no significant difference in quality of life. Conclusion:DREAMS START plus treatment as usual is clinically effective in reducing sleep disturbance in people living at home with dementia at 8 months, demonstrating sustained effectiveness beyond intervention delivery. DREAMS START is likely to be cost-effective, and delivery by non-clinically trained graduates increases potential for National Health Service implementation at scale. Limitations:We relied upon family carers' proxy and self-reported outcomes, with intervention participants potentially more invested and optimistic, increasing risk of bias. Additionally, based on our feasibility randomised controlled trial, we did not include actigraphy or another direct measure of sleep and activity. Future work:Studies should explore the longer-term effect of DREAMS START (we are following up participants at 2 years), and there should be an implementation study considering delivery and scaling up DREAMS START in real-world healthcare settings. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128761.

Group-level studies have highlighted the roles of aging, poor sleep, and brain atrophy in cognitive performance (CP) but have overlooked inter-individual variability. We predict CP from feature sets (demographic, subjective/objective sleep parameters, and regional brain morphometry) using multisite ENIGMA-Sleep data (n = 2,372). Linear and non-linear machine learning models were trained on the largest cohort (n = 845), and the best-performing models were validated on independent cohorts. Subsequently, based on the best-performing model on the largest cohort, we characterized feature importance and interactions across all cohorts. We observed that a combination of demographic, sleep, and brain parameters moderately predicted CP, with age emerging as the key predictor. Model explanations further suggested that age was the primary driver of prediction models, while sleep played a smaller role that varied across subgroups. These findings endorsed inter-individual variability and complex interaction between aging, sleep, brain, and CP.

Abstract Background/Aims Sleep disturbance is a defining feature of fibromyalgia (FM), contributing to pain, fatigue, cognitive dysfunction, and reduced quality of life. Effective management options remain limited. Cognitive behavioural therapy for insomnia (CBT-I) is effective in primary insomnia, but evidence in FM is sparse and access to face-to-face therapy is limited. Digital CBT-I (dCBT-I) offers a scalable, self-directed solution that may overcome these barriers. We conducted the first randomised controlled trial of dCBT-I in FM to evaluate its impact on quality of life and associated symptoms. Methods This single-blind randomised controlled trial evaluated Sleepio, a validated dCBT-I programme of six self-directed 20-minute sessions delivered over 12 weeks. Participants with a clinical diagnosis of FM, self-reported sleep disturbance, and cognitive complaints were recruited in Oxford, UK. After baseline assessment, participants were randomized to dCBT-I or a control group. All participants also received standardised sleep hygiene advice. The primary outcome was disease-specific quality of life measured by the revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes included insomnia severity (Insomnia Severity Index), actigraphy-derived sleep parameters, pain (SF36 Bodily Pain Scale), cognitive complaints (British Columbia Cognitive Complaints Inventory), sustained attention, and fear of movement (Tampa Scale of Kinesiophobia). Outcomes were collected online at baseline, 3 months, and 6 months. Analyses followed the intention-to-treat principle using constrained longitudinal data analysis. Ethical approval was obtained from South Central - Oxford B Research Ethics Committee (19/SC/0168). The study was pre-registered with clinicaltrials.gov (NCT05962138). Results Of 514 individuals contacted, 241 were screened, 132 were eligible, and 80 were randomised (42 dCBT-I, 38 control). The mean age was 46.6 (SD 14.5) years; 93.8% were female. Retention was high: 97.5% of participants provided outcomes at 3 months, and 83.8% at 6 months. In the dCBT-I group, 90.5% initiated the programme, and 54.8% reached the core session on sleep restriction therapy. At 3 months, there was no significant difference between groups in FIQR (mean difference −2.79; p = 0.3). At 6 months, however, dCBT-I participants demonstrated greater improvement in FIQR compared with controls (mean difference −5.45; 95% CI − 10.5 to − 0.4; p = 0.035), corresponding to a small-to-moderate effect size (Cohen’s d = −0.31). No significant between-group differences were observed for secondary outcomes. Conclusion In adults with FM, dCBT-I produced a sustained, clinically meaningful improvement in disease-related quality of life at 6 months compared with a sleep hygiene control. Although benefits were not observed across secondary outcomes, this trial provides the first controlled evidence that dCBT-I can address an important unmet need in FM. Digital behavioural therapies represent scalable, accessible, non-pharmacological interventions with potential for rapid integration into clinical care. Disclosure E. Kelleher: Grants/research support; National Institute for Health Research (NIHR) Pfizer Doctoral Fellowship (NIHR301808). A.J. Wall: Grants/research support; Grant is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), VA. V. Wanigasekera: None. R. Sharman: None. S. Kyle: None. I. Tracey: None. B. Seymour: Grants/research support; Grant is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), VA. A. Irani: Grants/research support; Grant is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), VA.

Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment for insomnia disorder. However, around 25% of the patients do not respond to the treatment, and only 40% achieve full remission. The current study investigates the therapeutic potential of light therapy as an add-on to CBT-I. Insomnia severity and questionnaire-related secondary outcomes were assessed at baseline, post-treatment and follow-up. Sleep diary-related variables and the cortisol awakening response were assessed at pre- and post-treatment. Linear mixed models were calculated for each outcome variable. The study included 42 patients with insomnia disorder. Reduction in insomnia severity did not significantly differ between groups from baseline to post-treatment (β = 0.35, SE = 1.31, p = 0.792). Regarding exploratory secondary outcomes, daytime sleepiness was significantly more reduced from baseline to follow-up in the CBT-I + light therapy group than in the CBT-I + placebo light group (β = -1.05, SE = 0.43, p = 0.020). There was no significant condition × time point interaction effect for any of the other secondary outcomes. The findings show no significant add-on effect of light therapy on insomnia severity. However, light therapy had a significant effect on daytime sleepiness that became evident only at the follow-up. Given that daytime functioning is of high clinical relevance for patients with insomnia disorder, daytime sleepiness should be further evaluated as treatment target and may be addressed with light therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: DRKS00029640.

Zahlreiche Menschen leiden unter Ein- und Durchschlafstörungen und den damit verbundenen Beeinträchtigungen der Stimmung und Leistungsfähigkeit – ein Beschwerdebild, das als Insomnie bezeichnet wird. Die Insomnie geht mit einem erheblichen Leidensdruck und einer deutlichen Einschränkung der Lebensqualität einher. Neben individuellen Belastungen verursacht sie auch volkswirtschaftliche Kosten, z. B. durch die vermehrte Inanspruchnahme des Gesundheitssystems sowie durch indirekte Folgen wie eine verringerte Arbeitsleistung. Dieser Band behandelt die Diagnostik und psychotherapeutische Behandlung der Insomnie, in Übereinstimmung mit aktuellen medizinisch-psychologischen Leitlinien und unter Berücksichtigung der neuesten wissenschaftlichen Evidenz. Zunächst werden Erkenntnisse zur Verbreitung der Insomnie in der Bevölkerung dargestellt sowie zum typischen Verlauf der Störung und zu häufig auftretenden komorbiden psychischen Störungen und körperlichen Erkrankungen. Daran anschließend werden Störungstheorien und -modelle präsentiert, die einen direkten Bezug zur psychotherapeutischen Behandlung der Insomnie haben. Das typische diagnostische Vorgehen bei Schlafstörungen wird erläutert, wobei v.a. auf diagnostische Verfahren eingegangen wird, die im psychotherapeutischen Kontext eingesetzt werden. Anschließend wird die in Leitlinien als Methode der Wahl empfohlene kognitive Verhaltenstherapie für Insomnie detailliert beschrieben. Diese Behandlung umfasst fünf psychotherapeutische Techniken: Bettzeitrestriktion, Stimuluskontrolle, kognitive Therapie, Psychoedukation und Entspannungsverfahren. Schließlich werden Ergebnisse zur Wirksamkeit der kognitiven Verhaltenstherapie für Insomnie sowie zur weit verbreiteten medikamentösen Behandlung von Insomnien dargestellt. Dabei wird deutlich, dass psychotherapeutische Verfahren kurzfristig ähnlich effektiv sind wie Schlafmittel, die mittel- und langfristigen Ergebnisse aber besser sind.

STUDY OBJECTIVES:Our study introduced the 2023 UK Biobank sleep questionnaire and described variation in sleep health dimensions and the prevalence of disordered sleep. METHODS:A questionnaire comprising validated measures and bespoke items was developed to capture key self-reported domains of sleep health and symptoms of sleep disorders. We quantified cohort prevalence of operationally defined sleep disorders and assessed the patterning of sleep health dimensions across key sociodemographic and clinically relevant variables. RESULTS:A total of 183 704 individuals completed at least one module of the questionnaire after email invitation (representing 56 per cent of those with an active email address), and an additional 1352 individuals completed via the participant website. In total 185 056 individuals were included in the analysis. Respondents were predominantly from a White ethnic background (96.8%), had a mean age of 69.9 (SD, 7.5) years, 57.9 per cent were female, and 25.5 per cent were in employment. Compared to non-respondents, respondents were more likely to be female, tended to be better educated, healthier, and exhibit lower levels of socioeconomic deprivation, although baseline sleep variables were similar between respondents and non-respondents. Around 40 per cent of respondents reported sleep duration less than 7 h, and 49 per cent reported poor sleep quality (Pittsburgh Sleep Quality Index >5). Approximately one-quarter (25.2%) met the criteria for at least one operationally defined sleep disorder, with insomnia being the most common (14.4%) followed by obstructive sleep apnea (8.0%), restless legs syndrome (4.1%), and frequent nightmares (3.7%). Sleep disorders were associated with higher levels of anxiety, depression, fatigue, and cognitive complaints. CONCLUSIONS:Poor sleep quality and operationally defined sleep disorders are common in the UK Biobank cohort. Sleep questionnaire data can now be integrated with a range of biomedical information to advance understanding of sleep.

Sleep disturbance is common and distressing for people with dementia, with no known safe, effective treatments. We previously developed and delivered DREAMS-START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, and demonstrated feasibility and acceptability. This randomised controlled trial (RCT) aimed to establish whether DREAMS-START is clinically-effective in reducing sleep disturbances in people with dementia at home after 8 months compared to usual care. We conducted a two-arm, multi-centre, parallel arms, superiority RCT with masked outcome assessment, recruiting dyads of people with dementia and sleep disturbance, and their family caregivers, in English community settings. Those meeting inclusion criteria were randomised (1:1) to DREAMS-START or usual treatment. DREAMS-START is a six-session, manualised intervention delivered by supervised, non-clinical graduates. Strategies were tailored and included routine, comfort, increasing light exposure, relaxation, and activity. Outcomes were collected at baseline, 4 months, and 8 months. The primary outcome was the Sleep Disorders Inventory (SDI) score at 8 months and analyses were intention to treat. Secondary outcomes for people with dementia included quality of life, daytime sleepiness, and neuropsychiatric symptoms and for family caregivers - quality of life, sleep disturbance, mood, and burden. Between February 2021 and March 2023, 377 participant dyads were randomised, 189 were allocated to usual treatment and 188 to intervention. Mean age of participants with dementia was 79.4 years (SD 9.0). 206 (54.6%) were women. Mean SDI score at 8 months was lower in the intervention arm versus usual treatment (15.16 [SD 12.77], n = 159, vs 20.34 [16.67], n = 163]; adjusted difference in means -4.70 (95% CI -7.65 to -1.74; p = 0.002). At 8 months carer sleep (difference in means 0.57 [95% CI 0.10 to 1.05]) and carer anxiety (difference in means -0.86 [95% CI -1.71 to -0.01]), were significantly lower in the intervention group than usual treatment. To our knowledge, this is the first and largest fully powered RCT of a multicomponent non-pharmacological intervention that improves sleep in people living at home with dementia and their caregivers, with sustained effectiveness beyond delivery. DREAMS-START has potential to be delivered at scale in health services.

INTRODUCTION:DREAMS-START is a multicomponent intervention targeting sleep disturbance in people with dementia. To enhance understanding of the DREAMS-START randomised controlled trial, which showed improved sleep in the intervention compared to the control arm, we conducted a process evaluation exploring (i) DREAMS-START delivery, (ii) behaviour change mechanisms and (iii) contextual factors impacting outcomes. METHODS:Mixed-methods design. We measured intervention adherence, fidelity and additional therapeutic process measures. We interviewed a sub-sample of intervention arm family carers and facilitators delivering DREAMS-START. We analysed data thematically guided by a prespecified theory of change logic model informed by the Theoretical Domains Framework. We measured movement using an actigraph worn by the person with dementia at baseline and at four- and eight-month follow-ups to explore potential mechanisms of action. RESULTS:Attendance was good (82.8% attended ≥4/6 sessions). Mean fidelity score (95.4%; SD 0.08) and median score for all four process measures assessed (5/5; IQR 5-5) were high. We interviewed 43/188 family carers and 9/49 DREAMS-START facilitators. We identified three overarching themes aligned with our model: (i) knowledge and facilitation enable behaviour change, (ii) increasing sleep pressure and developing skills to manage sleep disturbances and (iii) Establishing a routine and sense of control. We were unable to collect sufficient data for pre-specified actigraphy analyses. CONCLUSION:Despite competing demands, carers attended DREAMS-START. It promoted behaviour change through supportive in-session reflection, increasing carer knowledge and skills. This was embedded between sessions and actions were positively reinforced as carers experienced changes. Results will inform future implementation in clinical services.

In den westlichen industrialisierten Ländern (Europa, USA) ist das Restless-Legs-Syndrom (RLS) mit einer Prävalenz von 7–10 % eine der häufigsten neurologischen und schlafmedizinischen Erkrankungen. Diagnosekriterien wurden erstmalig 1995 von der International RLS Study Group festgelegt. Diese wurden im Jahr 2002 in einer Konsensuskonferenz revidiert und im Jahr 2003 publiziert. Die Diagnose wird anamnestisch anhand der klinischen Symptome gestellt. In den letzten Jahren wurden mehrere standardisierte RLS-Fragebögen für klinische Studien und für die tägliche Praxis entwickelt. Mit den speziell für dieses Krankheitsbild entwickelten Fragebögen können die diagnostische Sicherheit, der Schweregrad der Erkrankung, Nebenwirkungen der Behandlung, eine eventuelle Zunahme der Beschwerden unter Behandlung sowie Auswirkungen der RLS-Symptomatik erfasst werden, beispielsweise auf die Lebensqualität.

Importance:Cognitive behavioral therapy for insomnia (CBT-I) has been shown to reduce depressive symptoms, but the underlying mechanisms are not well understood and warrant further examination. Objective:To investigate whether CBT-I modifies negative bias in the perception of emotional facial expressions and whether such changes mediate improvement in depressive symptoms. Design, Setting, and Participants:A randomized clinical trial of digital CBT-I vs sleep hygiene education was conducted. Adults living in the UK who met diagnostic criteria for insomnia disorder and Patient Health Questionnaire-9 criteria (score ≥10) for depression were recruited online from the community and randomly assigned to either a 6-session digital CBT-I program or a sleep hygiene webpage. Participant recruitment took place between April 26, 2021, and January 24, 2022, and outcomes were assessed at 5 and 10 weeks post randomization. Data analysis was performed from December 1, 2022, to March 1, 2023. Main Outcomes and Measures:Coprimary outcomes were recognition accuracy (percentage) of happy and sad facial expressions at 10 weeks assessed with the facial expression recognition task. Secondary outcomes were self-reported measures of insomnia, depressive symptoms, affect, emotional regulation difficulties, worry, perseverative thinking, midpoint of sleep, social jet lag, and the categorization of and recognition memory for emotional words. Intention-to-treat analysis was used. Results:A total of 205 participants were randomly assigned to CBT-I (n = 101) or sleep hygiene education (n = 104). The sample had a mean (SD) age of 49.3 (10.1) years and was predominately female (165 [80.8%]). Retention was 85.7% (n = 175). At 10 weeks, the estimated adjusted mean difference for recognition accuracy was 3.01 (97.5% CI, -1.67 to 7.69; P = .15; Cohen d = 0.24) for happy facial expressions and -0.54 (97.5% CI, -3.92 to 2.84; P = .72; Cohen d = -0.05) for sad facial expressions. At 10 weeks, CBT-I compared with control decreased insomnia severity (adjusted difference, -4.27; 95% CI, -5.67 to -2.87), depressive symptoms (adjusted difference, -3.91; 95% CI, -5.20 to -2.62), negative affect (adjusted difference, -2.75; 95% CI, -4.58 to -0.92), emotional regulation difficulties (adjusted difference, -5.96; 95% CI, -10.61 to -1.31), worry (adjusted difference, -8.07; 95% CI, -11.81 to -4.33), and perseverative thinking (adjusted difference, -4.21; 95% CI, -7.03 to -1.39) and increased positive affect (adjusted difference, 4.99; 95% CI, 3.13-6.85). Improvement in negative affect, emotional regulation difficulties, and worry at week 5 mediated the effect of CBT-I on depression severity at 10 weeks (% mediated: 21.9% Emotion regulation difficulties; 24.4% Worry; and 29.7% Negative affect). No serious adverse events were reported to the trial team. Conclusions and Relevance:This randomized clinical trial did not find evidence that CBT-I engenders change in the perception of facial expressions at post treatment, despite improvements in insomnia and depressive symptoms. Early change in negative affect, emotional regulation difficulties, and worry mediated lagged depression outcomes and deserve further empirical scrutiny. Trial Registration:isrctn.org Identifier: ISRCTN17117237.

Pre-sleep worrying is associated with sleep disturbance, which in turn is associated with impaired affective wellbeing. However, studies examining the fine-grained temporal order of these variables are still lacking. In particular, within-person mediation of the association between pre-sleep worrying and the following day's affective wellbeing by subjective and objective indicators of sleep has not been tested yet. This study investigates the extent to which pre-sleep worrying predicts positive/negative affect the following day, and whether subjective/objective sleep disturbances are possible mediators for this relationship. Data from two experience sampling studies were pooled for the analyses, resulting in a total sample of 220 participants aged between 18 and 30 years (M = 23.2 years, SD = 2.8). The hypotheses were tested at both the between- and within-subject level using causal mediation analysis. The within-subject analyses revealed partial mediation of the relationship between pre-sleep worrying and positive as well as negative affect the next day by subjective sleep quality. By contrast, sleep as measured by actigraphy appears not to be relevant for the link between pre-sleep worrying and affective wellbeing the following day. Baseline levels of depressive symptoms and sleep disturbances did not moderate the associations between pre-sleep worrying, sleep indices and affective states the following day. Improving perceived sleep quality by addressing pre-sleep worrying could be a potential avenue to enhance affective wellbeing and promote better mental health in young adults.

Insomnia disorder is a prevalent health problem with adverse consequences for mental health and quality of life. Although insomnia disorder is defined in diagnostic systems as a subjective complaint about sleep, this understanding is not consistently applied in clinical settings. There remains a lack of clarity regarding the mechanisms underlying subjective sleep complaints and associated daytime impairments. This systematic umbrella review of meta-analyses aimed to compare subjective and objective health-related variables between patients with insomnia disorder and controls, characterizing insomnia comprehensively. After a systematic literature search, we included six meta-analyses comparing patients with insomnia disorder and controls in terms of subjective sleep (sleep diaries), objective sleep (polysomnography), peripheral brain-derived neurotrophic factor, cortisol, objective cognitive performance, blood pressure and EEG spectral power. The pattern of results suggests that differences between patients with insomnia disorder and healthy controls are largest and most consistent for subjective sleep. Objective between-group effect sizes were largest for unspecific stress markers such as brain-derived neurotrophic factor and cortisol. Variables expected to be abnormal in those with objective sleep deprivation, such as objective attention and alertness, showed minimal group differences. Also in terms of sleep, effect sizes for subjective variables were consistently larger than those for objective variables. Critical appraisal of the quality of the included meta-analyses using the AMSTAR 2 tool suggested moderate overall confidence in the results, whereby shortcomings in several critical domains such as pre-registration of the study protocol and justification for the inclusion of individual studies have been identified. Our findings highlight that insomnia disorder is characterized by large reductions in subjective sleep quality, in the absence of large objective alterations. This body of evidence supports a biopsychosocial conceptualization of chronic insomnia disorder with a strong psychological component.

The current article reviews adjustments that were made to the classification of sleep disorders in the 11th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-11) in comparison to the 10th revision of the coding system (ICD-10). A new chapter on sleep-wake disorders was introduced as chapter 7 in ICD-11, removing the distinction in nonorganic and organic sleep disorders that was used in ICD-10. The rationale for this was the commonsense notion that clinicians and researchers have difficulties to identify the etiology of insomnia and to establish causality between insomnia and coexisting conditions. With respect to sleep disorders that were previously included in chapter V "Mental and behavioural disorders" of the ICD-10, the following important changes were made: the diagnosis of insomnia disorder can now be made as comorbid with other mental disorders or physical illnesses if the insomnia symptoms are a focus of independent clinical attention, non-restorative sleep alone without difficulties initiating or maintaining sleep is not sufficient anymore to diagnose insomnia disorder and new diagnostic categories have been created, including insufficient sleep syndrome and sleep-related eating disorder. Future research will show whether the adjustments in ICD-11 will help clinicians to make reliable and clinically useful diagnoses and whether this improves routine clinical care for sleep disorders.

Abstract Introduction Insomnia is common in older adults with mild cognitive impairment (MCI) and predicts future cognitive decline. Cognitive Behavioural Therapy for insomnia (CBT-I) is the first-line treatment for insomnia but is often unavailable. We tested the feasibility of a randomised controlled trial comparing 12-weeks of digital CBT-I vs wait-listed control in older adults with MCI and insomnia. Methods This was an investigator-initiated (NCT05568381), parallel open-label randomised-controlled feasibility trial. Participants were randomised to digital CBT-I (Sleepio, 6-weekly sessions) or a wait-listed control (3 fortnightly online modules of a sleep health education package) via a secure centralised platform which was also used to collect the outcome data. This study was undertaken remotely without in-person visits. Potential participants were recruited through online advertising and a memory clinic in Sydney, Australia. Those who met initial eligibility were invited to a screening and informed consent telehealth consultation. Inclusion criteria included adults aged ≥50 years, with an Insomnia Severity Index (ISI)>10, who met the clinical criteria of MCI on a neuropsychological battery (performed over telehealth for participants recruited online). The primary outcomes were the proportion of participants who met screening and randomisation criteria. A secondary outcome was the effect sizes and 95%CIs of the difference in ISI between the groups at week 12. Results Recruitment occurred March 23, 2023 to August 11, 2023 stopping when we reached our pre-defined sample size (digital CBT-I=19; control=21; 30 females; mean [SD] age=59.7 years [7.3]; ISI=17.0 [3.7]). 37% of participants issued a pre-screening number (n=246), were eligible to attend online screening. 47% of those issued a screening number (n=90) were eligible to be randomised (n=42). All randomised participants (n=40) were recruited through the online pathway. At 12-weeks there was a difference in ISI between the digital CBT-I (mean±SE 7.8±1.1 points) and control groups (13.7±1.05 points) (Cohen’s D [95%CI] -1.6 [-2.4 to 2.1]). 79% of participants completed ≥4 out of the CBT-I 6 sessions. All adverse events were minor and transient. Conclusion This population can be recruited through online pathways and follow the protocol as well as adhere to the intervention of this remotely conducted trial. Support (if any) CogSleep CRE Seed Funding Grant. BigHealth- intervention in-kind.

ZusammenfassungViele Psychopharmaka haben sedierende Nebenwirkungen. Da zahlreiche psychische Erkrankungen mit Ein- und Durchschlafstörungen einhergehen, lassen sich diese Nebenwirkungen teilweise gezielt therapeutisch nutzen. Die sedierende Wirkung von Psychopharmaka kann jedoch auch ein schwerwiegendes Problem in der Behandlung darstellen. Tagesmüdigkeit, vermehrtes Schlafbedürfnis und daraus folgende körperliche Inaktivität können unter anderem zu verstärktem sozialen Rückzug, verstärkter depressiver Symptomatik, Gewichtszunahme, Herz-Kreislauf-Erkrankungen oder Obstruktiver Schlafapnoe führen. In diesem Kapitel wird eine Übersicht über Psychopharmaka gegeben, die häufig zur Sedierung führen.