Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- Geriatric depression scale
研究概览
简要总结
The goal of this randomized controlled clinical trial is to assess a novel cognitive-behavioral program for sleep and mental health using a multidomain web platform (eCBTi+) in participants with insomnia and subjective cognitive complaint. The main questions it aims to answer are:
- Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index [ISI], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety Index [GAI] and Geriatric Depression Scale [GDS]) compared to the control intervention
- Whether the eCBTi+ intervention improves cognitive abilities (subjective: Cognitive Failure Questionnaire [CFQ], objective: CANTAB executive functions composite score) compared to the control intervention
详细描述
Participants with insomnia disorder will complete:
- A phone interview
- Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices)
- 9 nights of at-home polysomnography with an EEG headband (3 times x 3 nights)
- 42 sleep diaries (3 times x 14 days)
- 42 days wearing an actigraphy device (3 times x 14 days)
- Online questionnaires
- Phone call for a check-in with a psychologist
- 3 cognitive testing sessions
- 10 modules of online information on health, over the course of 10 weeks
- In MRI subgroup: 2 in-person testing
Good sleeper participants will complete:
- A phone interview
- Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices)
- 3 nights of at-home polysomnography with an EEG headband
- 14 sleep diaries
- 14 days wearing an actigraphy device
- Online questionnaires
- 1 cognitive testing session
- 1 in person session for MRI.
In addition, researchers will compare outcomes from participants with insomnia and subjective cognitive complaint to a group of good sleepers to have normative values for imaging data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 60 years or older at the time of enrolment
- •Sleep Condition Indicator, SCI ≤ 16 and/or meeting DSM-V criteria based on the symptoms assessed by the SCI
- •subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 2 on any item)
- •ability to read and understand French or English
- •ability to use a smartphone or tablet, and access to home internet connection
- •If on hypnotic or psychotropic medication (including cannabis), being on stable dosage for at least 2 months prior to study entry
- •Score on the STOP-BANG questionnaire < 3 corresponding to participants with low risk of obstructive sleep apnea
- •located outside of Québec or Ontario
- •current hospitalization or planned major surgery
- •uncorrected severe hearing or vision impairment
- •reported diagnosis of major neurocognitive disorder or mild cognitive impairment (MCI)
- •performance suggestive of major neurocognitive disorder or MCI on T-MoCA < 17
- •reported diagnosis of schizophrenia or bipolar disorder
- •reported diagnosis or positive screen on the MINI for psychotic or bipolar disorders
- •high suicidal risk, as assessed by the modified Columbia-Suicide Severity Rating Scale
- •reported diagnosis or positive screening (apnea-hypopnea index >30 on a level 3 home sleep apnea test) for another untreated sleep disorder (e.g., sleep disordered breathing (OSA), REM sleep behavior disorder (RBD), restless legs syndrome (RLS); individuals with treated and controlled OSA (residual apnea-hypopnea index <30 and good therapeutic compliance) or RLS will not be excluded
- •current shift work
- •currently receiving CBT, having received CBTi in the past
- •frequent alcohol consumption having an impact on functionning (>10 glasses/week and having a significant impact on functionning)
- •illicit drugs use (more than once a month)
排除标准
- •for neuroimaging
- •psychotropic (including hypnotic) medication in the past 2 weeks
- •contraindications for MRI (e.g., pacemaker, metallic implant, claustrophobia)
- •unable or unwilling to come to one of the participating MRI centers (Montreal, Ottawa)
- •medical conditions likely to affect sleep; in particular:
- •current neurological disorder (e.g., epilepsy with any seizure in the past year, concussion in the past 3 months, multiple sclerosis, Parkinson's disease)
- •past history of brain lesion (e.g., brain hemorrhage, brain tumor, any condition having required brain surgery)
- •major surgery (i.e., requiring general anesthesia) in the past 3 months
- •untreated thyroid disorder
- •chronic pain syndrome self-reported as interfering with sleep (e.g., migraine, fibromyalgia, rheumatoid arthritis)
- •recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection)
- •active cancer or treated cancer with post-cancer treatment for less than 2 years
- •Inclusion/exclusion criteria for good sleepers Twenty-five good sleepers without cognitive complaint will be recruited as controls for the MRI session following the same criteria described above, except that SCI ≥ 17, not meeting the diagnostic criteria for chronic insomnia as assessed by the insomnia module of the SCID and no subjective cognitive complaint.
研究组 & 干预措施
online cognitive behavioral therapy for insomnia, anxiety and depression
10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week
干预措施: cognitive behavioral therapy for sleep, anxiety, and depression (Behavioral)
online intervention on nutrition and communication in older age
10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week
干预措施: education about healthy nutrition habits and communication in older age (Behavioral)
结局指标
主要结局
Geriatric depression scale
时间窗: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.
Objective cognitive performance based on a composite score for executive functions from the CANTAB
时间窗: At baseline and at 24 weeks after the start of the intervention
Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift \[IED\] and Stocking of Cambridge \[SOC\], ranging from 0 to 100 with higher scores reflecting poorer executive functions.
Insomnia severity index
时间窗: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
Subjective cognitive impairment based on cognitive failure questionnaire
时间窗: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Cognitive Failure Questionnaire (CFQ) total score as well as number of items with a score ≥ 3. The CFQ comprises 25 items and total score corresponds to the sum of all completed items, total score range from 0 to 100.
Geriatric anxiety index
时间窗: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
次要结局
- Objective sleep measures based on actigraphy: Sleep Latency(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Objective sleep measures based on actigraphy: Total Sleep Time(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Sleep quality based on the Pittsburgh sleep quality index(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Objective sleep measures based on actigraphy: Sleep Efficiency(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Subjective sleep measures based on sleep diaries: Wake After Sleep Onset(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Fractional anisotropy(At baseline, at 24 weeks after the start of the intervention)
- Objective sleep measures based on actigraphy: Wake After Sleep Onset(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Spatial Working Memory (SWM)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Objective sleep measures based on EEG: Sleep Efficiency(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Subjective sleep measures based on sleep diaries: Sleep Efficiency(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Subjective sleep measures based on sleep diaries: Total Sleep Time(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Adherence to treatment(At 10-12 weeks after the start of the intervention)
- Objective sleep measures based on EEG: Slow Wave Sleep(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Subjective sleep measures based on sleep diaries: Sleep Latency(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Spatial Span (SSP)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Paired Associates Learning (PAL)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Resting-state measures(At baseline, at 24 weeks after the start of the intervention)
- GABA/glutamate ratio from magnetic resonance spectroscopy(At baseline, at 24 weeks after the start of the intervention)
- Objective sleep measures based on EEG: Sleep Latency(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Objective sleep measures based on EEG: Total Sleep Time(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Objective sleep measures based on EEG: Wake After Sleep Onset(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Objective sleep measures based on EEG: Slow Wave Activity(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)(At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention)
- Treatment-mediated association between changes in sleep and cognition(At 10-12 weeks and at 24 weeks after the start of the intervention)
- Satisfaction from System Usability Scale(At 10-12 weeks after the start of the intervention)
- Memory encoding fMRI activations(At baseline, at 24 weeks after the start of the intervention)
- Cognitive performance (classical neuropsychological tests)(At baseline, at 24 weeks after the start of the intervention)
- Cortical thickness measures(At baseline, at 24 weeks after the start of the intervention)
- Technology acceptance(At 10-12 weeks after the start of the intervention)
研究者
Thien Thanh Dang-Vu
Professor, Neurologist; Director, Sleep, Cognition & Neuroimaging Laboratory (SCNLab)
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal