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Trial registered on ANZCTR


Registration number
ACTRN12620000055909
Ethics application status
Approved
Date submitted
13/12/2019
Date registered
23/01/2020
Date last updated
10/03/2020
Date data sharing statement initially provided
23/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SleepFix for Insomnia in Primary Care
Scientific title
The feasibility of a mobile application (SleepFix) delivering behavioural therapy for Insomnia in primary care
Secondary ID [1] 299708 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a sub-study using a mobile app tested in the following studies: ACTRN12618000060246, ACTRN12618001668291

Health condition
Health condition(s) or problem(s) studied:
Insomnia 315059 0
Condition category
Condition code
Mental Health 313389 313389 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General practitioners (GPs) will be briefed by the study coordinator and invited to provide consent (in person). As part of the study, GPs will assess new or existing patients with either pre-existing or suspected chronic insomnia (minimum 3 months chronicity) using their own clinical judgement and a 3-item DSM-5 checklist.

Following screening by the GP, eligible patients will be invited to participate in the study through an invitation (SleepFix prescription) provided by the GP. This will analogous to prescribing medication using a script. Thereafter, participants will complete the following procedures at home in their own time. The invitation will direct all interested potential participants to a dedicated website (www.gpsfix.com.au) where they will use the unique log-in details provided on the invitation to gain access to the website. Participants will undergo additional screening on this webpage. If eligible, participants will provide informed consent digitally.

The website will provide participants with a unique code (access code) which is used to gain access to the app (i.e. therapy) once downloaded from the iOS or Google Play store. All expectation setting and instructions for use of SleepFix application will be delivered via the same study website used for onboarding. Short video vignettes will be used to explain these concepts with text to reinforce and will continue to be available throughout the 6-week intervention period (3 weeks of therapy + 3 additional weeks of optional use). The first video explains sleep consolidation therapy, how sleep efficiency is calculated and the concept of sleep pressure. The second video summarises how the app works including how data is used to calculate and adjust sleep window based on sleep efficiency, along with the four stages to the program. The third video will demonstrate how to use the app. The study website will also include a link to a manual to further explain the mobile application, how the treatment works and how to download and use the app

This entire onboarding process conducted online will be completed in under 20 minutes. All participants will be provided with a Fitbit with sleep-tracking capability which will sync objective sleep data into their SleepFix sleep diary.

Sleep retraining therapy aims to reduce excess time spent in bed and reset sleep by matching time in bed (minimum of five and a half hours) to total sleep time (TST). Once an 80% rate of sleep efficiency (time asleep divided by time in bed multiplied by 100) is achieved, recommended time in bed is extended by fifteen minutes (normally by retiring to bed earlier). Conversely, if sleep efficiency is less than 80% for 3 consecutive days, time in bed is reduced by fifteen minutes. The SleepFix smartphone application replicates this clinical process and calculates the sleep window based on sleep efficiency scores obtained from user input and objective sensor data from the wearable fitness tracker. At commencement of SleepFix application, participants enter average sleep and bedtime data into the smartphone application. The app prescribes a personalised bedtime and rising time. Each morning, participants complete their SleepFix sleep diary. This data is used by the app to automatically titrate their sleep window. There is no interaction required with the SleepFix app at night.

There are four stages to the SleepFix application and participants will progress based on sleep anchor times (sleep onset and offset) and sleep efficiency (>80%). Stage 1 and 2 require participants to adhere to bedtimes whilst stages 3 and 4 focus on sleep efficiency. Participants will engage with the therapy every night of the 3 week study period with an optional 3 weeks of continued therapy (decided by participant). Data will be collected during weeks 1-6 inclusive.

Adherence to the therapy will be assessed by the number of sleep diary entries and daily sleep-wake parameters: time in bed, sleep efficiency measured using data from the sleep diary and/or objective sensor data from the wearable fitness tracker.
Intervention code [1] 315972 0
Treatment: Devices
Comparator / control treatment
This study is a non-randomised, open label repeated-measures (pre-to-post) trial. All participants will receive the mobile application treatment. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321873 0
App uptake will be measured based on the number of access codes activated compared to the number of prescriptions handed out.
Timepoint [1] 321873 0
At the beginning of the study for each participant..
Secondary outcome [1] 376548 0
Acceptability of the app for insomnia patients will be assessed by the number of in-app sleep diary entries logged.
Timepoint [1] 376548 0
The number of sleep diaries entered by participants will be collected ongoing during the study.
Secondary outcome [2] 378283 0
Acceptability of the app for insomnia patients will be assessed by the completion of Insomnia Severity Index (ISI).
Timepoint [2] 378283 0
Measurements will be at week 6
Secondary outcome [3] 378284 0
Acceptability will be assessed by the Treatment Acceptability Questionnaire
Timepoint [3] 378284 0
Measurements will be at week 6
Secondary outcome [4] 378285 0
Acceptability will be assessed by the Internet Evaluation and Utility Questionnaire administered to participants .
Timepoint [4] 378285 0
Measurements will be at week 6.
Secondary outcome [5] 378286 0
Acceptability will be assessed by interviews and surveys with participants and GPs, respectively.
Timepoint [5] 378286 0
Measurements will be at week 6
Secondary outcome [6] 378287 0
Insomnia severity will be assessed using the Insomnia Severity Index (ISI).
Timepoint [6] 378287 0
Measurements will be at baseline and week 6.
Secondary outcome [7] 378288 0
Level of sleep disturbance will be assessed by the Sleep Difficulty Score questionnaire.
Timepoint [7] 378288 0
Measurements will be at baseline and week 6.
Secondary outcome [8] 378289 0
Sleep quality will be measured with a 1-item questionnaire derived from the Pittsburgh Sleep Quality Index.
Timepoint [8] 378289 0
Measurements will be at baseline and week 6.
Secondary outcome [9] 378290 0
Global sleep quality will be measured using the Pittsburgh Sleep Quality Index.
Timepoint [9] 378290 0
Measurements will be at baseline and week 6.
Secondary outcome [10] 378291 0
Depression will be measured by Patient Health Questionnaire (PHQ-9).
Timepoint [10] 378291 0
Measurements will be at baseline and week 6.
Secondary outcome [11] 378292 0
Anxiety will be measured by the Generalised Anxiety Disorder Scale (GAD).
Timepoint [11] 378292 0
Measurements will be made at baseline and week 6.
Secondary outcome [12] 378293 0
Daytime fatigue will be measured by the Flinders Fatigue Scale.
Timepoint [12] 378293 0
Measurements will be made at baseline and week 6.
Secondary outcome [13] 378294 0
Daytime sleepiness will be measured by the Epworth Sleepiness Scale .
Timepoint [13] 378294 0
Measurements will be made at baseline and week 6.

Eligibility
Key inclusion criteria
Adults 18 years +. GP diagnosed insomnia using a DSM-5 checklist. Smartphone access (Android or iOS). English speaker
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy (self-reported). Shift workers. Epilepsy. Bipolar Disorder. Chronic pain conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
With 110 patients recruited, and an uptake rate falling within the range of 60-80%, the width of each limb of the 95% confidence limits within +/- 14 percentage points. We estimate the uptake rate to be approximately 50% (ie 55 of 110 patients) based on previous experiences and study completion rates of digital CBTi studies and a recent study we conducted using SleepFix in a community-based sample (manuscript in preparation).

For pre-post change in ISI score, assuming a standard deviation for the change in ISI to be 6.65 (Ritterband JAMA Psychiatry. 2017;74(1):68-75.). With 20% loss to follow-up (ie 44 of 55 completing) there would be 80% power at a 2-tailed significance level of 0.05 to detect a 3-point decrease in ISI.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304182 0
Government body
Name [1] 304182 0
Sydney Health Partners Medical Research Future Fund
Address [1] 304182 0
Level 3, The Hub | Charles Perkins Centre (D17)
The University of Sydney NSW 2006
Country [1] 304182 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road
Glebe NSW, 2037
Country
Australia
Secondary sponsor category [1] 304414 0
None
Name [1] 304414 0
Address [1] 304414 0
Country [1] 304414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304652 0
Sydney Local Health District
Ethics committee address [1] 304652 0
Research Ethics and Governance Office (REGO)
Suite 210A, Level 2,
RPAH Medical Centre
100 Carillon Ave
NEWTOWN NSW 2042
Ethics committee country [1] 304652 0
Australia
Date submitted for ethics approval [1] 304652 0
17/10/2019
Approval date [1] 304652 0
04/12/2019
Ethics approval number [1] 304652 0

Summary
Brief summary
Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. To date, there is a paucity of research in insomnia treatments options in primary care, which is surprising considering the number of patients with insomnia who are managed by GPs. The current study will test the feasibility of a mobile application (SleepFix) delivering behavioural therapy for insomnia in primary care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97734 0
A/Prof Christopher Gordon
Address 97734 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 97734 0
Australia
Phone 97734 0
+61 2 9114 0000
Fax 97734 0
Email 97734 0
christopher.gordon@sydney.edu.au
Contact person for public queries
Name 97735 0
A/Prof Christopher Gordon
Address 97735 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 97735 0
Australia
Phone 97735 0
+61 2 9114 0000
Fax 97735 0
Email 97735 0
christopher.gordon@sydney.edu.au
Contact person for scientific queries
Name 97736 0
A/Prof Christopher Gordon
Address 97736 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 97736 0
Australia
Phone 97736 0
+61 2 9114 0000
Fax 97736 0
Email 97736 0
christopher.gordon@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results