💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion
* 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
Exclusion
* 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)
Additional exclusion criteria 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.