Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05173844




Registration number
NCT05173844
Ethics application status
Date submitted
13/12/2021
Date registered
30/12/2021
Date last updated
18/04/2024

Titles & IDs
Public title
Digital Sleep Therapy for Older Adults With Cognitive Impairment
Scientific title
E-buddy Supported Digital Sleep Therapy for Older Adults With Cognitive Impairment
Secondary ID [1] 0 0
X21-0434
Universal Trial Number (UTN)
Trial acronym
ExCEED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Type; Sleep Disorder 0 0
Cognitive Impairment 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Insomnia Severity Index
Timepoint [1] 0 0
Change score from baseline at 8 weeks
Secondary outcome [1] 0 0
Change in self-reported cognitive impairment
Timepoint [1] 0 0
Change score from baseline at 8 weeks
Secondary outcome [2] 0 0
Change in sleep metrics and quality
Timepoint [2] 0 0
Change score from baseline at 8 weeks
Secondary outcome [3] 0 0
Change in depressive symptoms
Timepoint [3] 0 0
Change score from baseline at 8 weeks
Secondary outcome [4] 0 0
Change in anxiety symptoms
Timepoint [4] 0 0
Change score from baseline at 8 weeks
Secondary outcome [5] 0 0
Change in fatigue
Timepoint [5] 0 0
Change score from baseline at 8 weeks
Secondary outcome [6] 0 0
Change in daytime sleepiness
Timepoint [6] 0 0
Change score from baseline at 8 weeks
Secondary outcome [7] 0 0
Change in quality of Life
Timepoint [7] 0 0
Change score from baseline at 8 weeks
Secondary outcome [8] 0 0
Digital literacy
Timepoint [8] 0 0
The questionnaire will only be collected at baseline

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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05173844
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Gordon, PhD
Address 0 0
Macquarie University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christopher Gordon
Address 0 0
Country 0 0
Phone 0 0
+61 2 9351 0586
Fax 0 0
Email 0 0
C.Gordon@mq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05173844