Clinical trial NCT05173844: Digital Sleep Therapy for Older Adults with Cognitive Impairment
Official title: E-buddy Supported Digital Sleep Therapy for Older Adults with Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia Type; Sleep Disorder
Cognitive Impairment
Lead sponsor: Woolcock Institute of Medical Research
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the efficacy of digital Behavioural Therapy for Insomnia (dBTi) compared to online sleep health education (control) at reducing insomnia symptom severity (Insomnia Severity Index: ISI) in older adults (50+ years) with subjective cognitive impairment from baseline compared to week 8.

Detailed description: Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population. Recent work shows that sleep plays a critical role in optimising brain function and sleep disturbance is highly prevalent in individuals with cognitive impairment.

The investigators will conduct a fully online study comparing 3-weeks of digital brief behavioural therapy for insomnia (dBBTi) (in addtiotion to an extra optional 3 weeks) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix mobile application delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.

At baseline, all participants will complete self-reported measures of insomnia, cognition ,sleep, fatigue, sleepiness , anxiety, depression, quality of life and digital health literacy. These will be repeated at follow-up at weeks 8, 16.

Eligibility criteria: Inclusion Criteria:

* Aged 50 years and older
* Insomnia Severity Index score ≥10
* Self-reported subjective cognitive impairment as defined as moderate subjective cognitive complaints (i.e. answers YES to have cognitive concerns OR thinking and memory skills are worse than same-age peers on the online screening)
* English speaking
* Access to a smartphone and willingness/proficiency to use a mobile app for healthcare
* Able to give informed online consent

Exclusion Criteria:

* Neurological (e.g. Parkinson's, epilepsy) and major psychiatric disease (e.g. current major depression), dementia, history of cerebrovascular events (stroke, TIA); history of head injury with loss of consciousness \> 30mins;
* Self-reported jetlag symptoms due to travel in the last 7 days;
* Current illicit substance use or alcohol intake suggestive of a hazardous or harmful pattern;
* Shift-work;
* Medical conditions with known effects on cognition and sleep (e.g. cancer with chemotherapy);
* Diagnosed obstructive sleep apnoea, or other sleep disorder including REM Sleep Behaviour Disorder, Restless Legs Syndrome or Narcolepsy.

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Change score from baseline at 8 weeks
Secondary outcomes:
measure: Change in self-reported cognitive impairment
timeFrame: Change score from baseline at 8 weeks
measure: Change in sleep metrics and quality
timeFrame: Change score from baseline at 8 weeks
measure: Change in depressive symptoms
timeFrame: Change score from baseline at 8 weeks
measure: Change in anxiety symptoms
timeFrame: Change score from baseline at 8 weeks
measure: Change in fatigue
timeFrame: Change score from baseline at 8 weeks
measure: Change in daytime sleepiness
timeFrame: Change score from baseline at 8 weeks
measure: Change in quality of Life
timeFrame: Change score from baseline at 8 weeks
measure: Digital literacy
timeFrame: The questionnaire will only be collected at baseline
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Macquarie University
name: Christopher Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: