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Insomnia Type; Sleep DisorderExCEEDNCT05173844

Digital Sleep Therapy for Older Adults With Cognitive Impairment

A study testing SleepFix mobile application in people with Insomnia Type; Sleep Disorder and Cognitive Impairment, run by Woolcock Institute of Medical Research at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
SleepFix mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteAustralia
Study dates
10 Nov 2022to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Woolcock Institute of Medical Research

    Sydney, New South Wales, 2109

Other trials in Australia

About this study

Official title: E-buddy Supported 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.

Read the 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.

Being tested
SleepFix mobile application
Medical subject headings
Sleep Wake Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SleepFix mobile applicationOther

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

Study groups in NCT05173844
Study groupRoleWhat they receive
TreatmentExperimentalParticipants will be instructed to use SleepFix mobile application for 3 weeks with an optional 3 weeks of additional therapy. Participants will complete daily sleep diary entries (which take less than 1 min) which are used to calculate the sleep window titration. SleepFix incorporates sleep restriction and stimulus control which have been shown to be the most powerful components of cognitive-behavioural therapy for insomnia - CBTi. It has been shown to produce rapid, clinically-meaningful insomnia symptom reduction in a shorter period of time compared with both face-to-face and digital CBTi. SleepFix does not require the user to complete modules and multiple components such as other digital CBTi programs (e.g. Sleepio). Further, it is personalised to the individual's current sleep patterns and requires minimal engagement compared to full CBTi.
Receives: Other: SleepFix mobile application
ControlNo interventionParticipants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are 3 modules provided bi-weekly and the information in these modules is presented as a subdomain through the study website. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Insomnia Severity Index

    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.

    Measured: Change score from baseline at 8 weeks

Secondary outcomes (8)
  1. Change in self-reported cognitive impairment

    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.

    Measured: Change score from baseline at 8 weeks

  2. Change in sleep metrics and quality

    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.

    Measured: Change score from baseline at 8 weeks

  3. Change in depressive symptoms

    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.

    Measured: Change score from baseline at 8 weeks

  4. Change in anxiety symptoms

    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.

    Measured: Change score from baseline at 8 weeks

  5. Change in fatigue

    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.

    Measured: Change score from baseline at 8 weeks

  6. Change in daytime sleepiness

    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.

    Measured: Change score from baseline at 8 weeks

  7. Change in quality of Life

    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).

    Measured: Change score from baseline at 8 weeks

  8. Digital literacy

    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.

    Measured: The questionnaire will only be collected at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start10 Nov 2022
  3. Primary completion1 Jul 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173844
Sponsor's protocol ID
X21-0434
Acronym
ExCEED
Status last verified
Jun 2025
First submitted
13 Dec 2021
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All de-identified data may be made available upon the Principal investigator's agreement with an amendment required to the approving ethics board.

Questions about this trial

What is this clinical trial studying?

A study testing SleepFix mobile application in people with Insomnia Type; Sleep Disorder and Cognitive Impairment, run by Woolcock Institute of Medical Research at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insomnia Severity Index (time frame: Change score from baseline at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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