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Completed

NCT Number: NCT05173844

Digital Sleep Therapy for Older Adults With Cognitive Impairment

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woolcock Institute of Medical Research

Sydney, New South Wales, 2109, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SleepFix mobile application

Other

Digital behavioural therapy (dBTi) mobile application SleepFix® is specifically designed to treat insomnia and has been shown to be engaging and clinically efficacious.

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: Change score from baseline at 8 weeks

    Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.

Secondary outcomes

  1. Change in self-reported cognitive impairment

    Time frame: Change score from baseline at 8 weeks

    The British Columbia Cognitive Complaints Inventory (BC-CCI)12 is a 6-item tool to assess self-perceived cognitive decline. It probes any perceived problems associated with cognition, memory, expressive language, word finding, processing speed, and problem solving in reflection of the last 7 days. Answers for each question range from 0 (= "not at all") to 3 (= "Very much"). Scores are summed to a total out of 18 that reflects the cognitive complaint severity. The BC-CCI has a short reference period to ensure that it only reflects complaints outside of the treatment window.

  2. Change in sleep metrics and quality

    Time frame: Change score from baseline at 8 weeks

    The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-reported questionnaire which assesses sleep quality and disturbances over the previous 2 weeks so only variables across a time-period not including the therapy window are measured. Seven component scores are derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.

  3. Change in depressive symptoms

    Time frame: Change score from baseline at 8 weeks

    The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a "Yes/No" format. The shortened form comprises of 15 items chosen from the Geriatric Depression Scale-Long Form. These 15 items were chosen because of their high correlation with depressive symptoms in previous validation studies. Of the 15 items, 10 indicate the presence of depression when answered positively while the other 5 are indicative of depression when answered negatively. This form can be completed in approximately 5 to 7 minutes, making it ideal for people who are easily fatigued or are limited in their ability to concentrate for longer periods of time.

  4. Change in anxiety symptoms

    Time frame: Change score from baseline at 8 weeks

    The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety by asking how often participants have experienced symptoms in the previous two weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.

  5. Change in fatigue

    Time frame: Change score from baseline at 8 weeks

    The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from "not at all" = 0 to "extremely" = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue.

  6. Change in daytime sleepiness

    Time frame: Change score from baseline at 8 weeks

    The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire that provides a rating of general sleepiness in the last two weeks. Participants are asked to rate each item on a 4-point Likert scale from "would never dose" = 0 to "high chance of dozing" = 3. All items are summed with total scores ranging from 0-26 where scores >10 and >15 reflect above-average and pathological daytime sleepiness, respectively.

  7. Change in quality of Life

    Time frame: Change score from baseline at 8 weeks

    The EuroQol five-dimensional (EQ-5D) is a well-validated, generic instrument for measuring health related quality of life at the time of completion. The self-reported questionnaire is comprised of 2 components including: (1) Health state description - measured in terms of 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and (2) evaluation - where participants are asked to evaluate their overall health using a visual analogue scale. In Part 1, each item is assigned a level (ranging from "indicating no problem"1 - "indicating unable to/extreme problems" - 5) according to the response and this descriptive data is used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).

  8. Digital literacy

    Time frame: The questionnaire will only be collected at baseline

    The eHEALS Literacy Scale (eHEALS) will be used to assess digital health literacy. eHEALS is an 8-item, 5-point Likert-type questionnaire that measures a participant's perception of, and ability toward electronic health information27. Responses range from "strongly disagree" =1, to "strongly agree" = 5. Total scores are summed to range from 8 to 40 where lower scores indicate lower self-reported digital health literacy.

Sponsors and collaborators

Lead sponsor

Woolcock Institute of Medical Research

Other

Registry information

Official study title

E-buddy Supported Digital Sleep Therapy for Older Adults With Cognitive Impairment

Acronym: ExCEED

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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