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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05067569




Registration number
NCT05067569
Ethics application status
Date submitted
8/09/2021
Date registered
5/10/2021

Titles & IDs
Public title
App-delivered Sleep ThERapy for Older Individuals With Insomnia
Scientific title
App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)
Secondary ID [1] 0 0
X21-0265
Universal Trial Number (UTN)
Trial acronym
ASTEROID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - SleepFix mobile application
BEHAVIORAL - Sleep Health Education

Experimental: Digital brief behavioural therapy for insomnia - Participants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks.

Active comparator: Sleep Health Education wait-list 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 three modules provided bi-weekly with information about sleep health and broad details about managing sleep disturbances. Participants will receive a link to this information as each module is made available.

Upon completion of the study (week 26), the control group will receive free access to the SleepFix mobile application.


BEHAVIORAL: SleepFix mobile application
The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.

BEHAVIORAL: Sleep Health Education
These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. 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. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in insomnia symptom severity
Timepoint [1] 0 0
Change score from baseline at 8 weeks
Secondary outcome [1] 0 0
Change in subjective sleep quality
Timepoint [1] 0 0
Change score from baseline at 8 weeks
Secondary outcome [2] 0 0
Change in sleep onset latency
Timepoint [2] 0 0
Change score from baseline at 8 weeks
Secondary outcome [3] 0 0
Change in wake after sleep onset
Timepoint [3] 0 0
Change score from baseline at 8 weeks
Secondary outcome [4] 0 0
Change in total sleep time
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
Change in depressive symptoms
Timepoint [8] 0 0
Change score from baseline at 8 weeks
Secondary outcome [9] 0 0
Change in anxiety
Timepoint [9] 0 0
Change score from baseline at 8 weeks
Secondary outcome [10] 0 0
Change in self-reported cognition
Timepoint [10] 0 0
Change score from baseline at 8 weeks
Secondary outcome [11] 0 0
Engagement
Timepoint [11] 0 0
Baseline, week 8
Secondary outcome [12] 0 0
The effect of baseline digital health literacy on therapy efficacy
Timepoint [12] 0 0
Baseline, week 8

Eligibility
Key inclusion criteria
1. Older adults aged = 60 years
2. Able to give informed online consent
3. Insomnia Severity Index = 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
4. English fluency
5. Access to a smartphone and willingness/proficiency to use a mobile app
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Shift-workers
2. Travel to a destination with >2 hours time-difference (within 30-days)
3. Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
4. Diagnosed sleep disorders other than insomnia
5. Regular sleep medications or sleep devices (>2 times a week over last 6 months)
6. Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
7. Drive for work/operate heavy machinery

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/05/2024
Actual
Sample size
Target
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2037 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ronald Grunstein, MD, PhD
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
The study data will be available following all analyses.
Available to whom?
Contact the Coordinating Principal Investigator for access to data.
Available for what types of analyses?
How or where can data be obtained?


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/NCT05067569