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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05173844
Registration number
NCT05173844
Ethics application status
Date submitted
13/12/2021
Date registered
30/12/2021
Titles & IDs
Public title
Digital Sleep Therapy for Older Adults With Cognitive Impairment
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Scientific title
E-buddy Supported Digital Sleep Therapy for Older Adults With Cognitive Impairment
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Secondary ID [1]
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X21-0434
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Universal Trial Number (UTN)
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Trial acronym
ExCEED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insomnia Type; Sleep Disorder
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Cognitive Impairment
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - SleepFix mobile application
Experimental: Treatment - Participants 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.
No intervention: Control - Participants 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.
Other interventions: SleepFix mobile application
Digital behavioural therapy (dBTi) mobile application SleepFix® is specifically designed to treat insomnia and has been shown to be engaging and clinically efficacious.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Insomnia Severity Index
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Assessment method [1]
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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.
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Timepoint [1]
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Change score from baseline at 8 weeks
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Secondary outcome [1]
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Change in self-reported cognitive impairment
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Assessment method [1]
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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.
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Timepoint [1]
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Change score from baseline at 8 weeks
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Secondary outcome [2]
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Change in sleep metrics and quality
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Assessment method [2]
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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.
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Timepoint [2]
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Change score from baseline at 8 weeks
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Secondary outcome [3]
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Change in depressive symptoms
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Assessment method [3]
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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.
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Timepoint [3]
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Change score from baseline at 8 weeks
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Secondary outcome [4]
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Change in anxiety symptoms
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Assessment method [4]
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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.
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Timepoint [4]
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Change score from baseline at 8 weeks
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Secondary outcome [5]
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Change in fatigue
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Assessment method [5]
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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.
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Timepoint [5]
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Change score from baseline at 8 weeks
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Secondary outcome [6]
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Change in daytime sleepiness
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Assessment method [6]
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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.
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Timepoint [6]
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Change score from baseline at 8 weeks
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Secondary outcome [7]
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Change in quality of Life
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Assessment method [7]
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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).
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Timepoint [7]
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Change score from baseline at 8 weeks
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Secondary outcome [8]
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Digital literacy
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Assessment method [8]
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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.
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Timepoint [8]
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The questionnaire will only be collected at baseline
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Eligibility
Key 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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
128
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Sydney
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Recruitment postcode(s) [1]
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2109 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05173844
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christopher Gordon, PhD
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Address
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Macquarie University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Christopher Gordon
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Address
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Country
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Phone
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+61 2 9351 0586
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All de-identified data may be made available upon the Principal investigator's agreement with an amendment required to the approving ethics board.
Supporting document/s available: Study protocol, Informed consent form (ICF)
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When will data be available (start and end dates)?
The study data will be available following all analyses.
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Available to whom?
Contact the Coordinating Principal Investigator for access to data.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05173844