Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000778785
Ethics application status
Approved
Date submitted
16/05/2022
Date registered
31/05/2022
Date last updated
18/09/2023
Date data sharing statement initially provided
31/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Home-Based Digital Treatments for Insomnia.
Scientific title
A Randomized Controlled Trial Comparing Home-Based Intensive Sleep Retraining to Online CBT-I and The Combination for the Treatment of Chronic Insomnia Disorder.
Secondary ID [1] 307142 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia 326325 0
Condition category
Condition code
Mental Health 323636 323636 0 0
Other mental health disorders
Neurological 323768 323768 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three intervention groups.
1. THIM
Participants in the THIM group will self-select a night convenient for them to undergo treatment, i.e., a night with minimal activities the following day to mitigate the daytime effects of sleep restriction (typically on the weekend). Participants will connect the device (posted to them by study researchers) to their internet-enabled smartphone via an anonymous account created for them by the study researchers and follow the THIM app instructions to set up the device. Participants will then lie down in bed and attempt to fall asleep at their habitual bedtime (calculated from pre-treatment sleep diaries, likely around 10pm) while wearing THIM on the index finger of their dominant hand. THIM will emit subtle vibratory stimuli approximately every 30 seconds to which the participant must respond by tapping their finger against their thumb. When the participant fails to respond to the stimuli, typically shortly after entering light sleep, THIM will infer that they have fallen asleep and subsequently wake the participant by emitting a high intensity vibration. The participant will remain awake for a 2-minute break before THIM instructs them to attempt to fall asleep again on the next trial. This process (known as Intensive Sleep Retraining) will continue overnight for 10 hours (likely around 8am). Study researchers will be available via phone and email.
After the treatment ends in the morning, participants will remain awake (confirmed by sleep tracker data) until at least one hour before their habitual bedtime the night after (likely around 9pm). They will be strongly encouraged to not drive, operate heavy machinery or make important decisions until they feel recovered. After the anticipated long recovery sleep, participant will be advised to maintain a consistent sleep phase (between 10:00 PM and 8:00 AM) and sleep opportunity (maximum nine hours) in the six weeks following treatment.
2. Sleep Healthy Using The Internet (SHUTi)
Participants will receive a subscription from study researchers to the established six-module self-guided online program. The content of the six modules are as follows: 1) overview of insomnia and setting treatment goals, 2) sleep restriction therapy and sleep habits, 3) stimulus control therapy, 4) sleep education, 5) cognitive therapy, 6) relapse prevention. Participants will complete each weekly module over six weeks on their computers (30-60 minutes per module) and implement the activities provided in these modules within this time, such as mildly restricting their sleep in week 2. Study researchers will be available via phone and email.
3. The combination (THIM followed by SHUTi)
Participants in the combined treatment group will undergo THIM as described above during the first week of SHUTi (module 1), prior to the administration of sleep restriction therapy (module 2) and stimulus control therapy (module 3). They will then undergo the remaining 3 modules as planned (all 6 modules will be completed). Consequently, their time commitment is still six weeks in duration.
Study researchers will be available to all participants via phone and email for technical support, to monitor safety (via study measures, e.g., sleep diaries, weekly questionnaires), and to follow up on attrition of study measures. Study researchers will not play an active role in treatment.
Intervention code [1] 323597 0
Treatment: Devices
Intervention code [2] 323598 0
Treatment: Other
Comparator / control treatment
The control condition is a waitlist control group. Participants in this condition will complete all measurements that the intervention condition completes. They will then be re-randomised to the active intervention conditions after completing the 'post-treatment' assessments (i.e., after 10 weeks).
Control group
Active

Outcomes
Primary outcome [1] 331389 0
Mean self-reported total wake time on the Sleep/Wake Diary.
Timepoint [1] 331389 0
Four weeks post-treatment completion and two-month follow up (primary endpoint)
Secondary outcome [1] 409690 0
Mean Insomnia Severity Index score
Timepoint [1] 409690 0
Four weeks post-treatment completion and two-month follow up
Secondary outcome [2] 409691 0
Mean total wake time from a sleep tracker device.
Timepoint [2] 409691 0
Four weeks post-treatment completion and two-month follow up
Secondary outcome [3] 409692 0
Mean score on the Daytime Feelings and Functioning Scale
Timepoint [3] 409692 0
Four weeks post-treatment completion and two-month follow up
Secondary outcome [4] 409693 0
Mean score on the Dysfunctional Beliefs About Sleep scale
Timepoint [4] 409693 0
Four weeks post-treatment completion and two-month follow up
Secondary outcome [5] 409694 0
Mean score on the SF-36 (Short-Form 36 items) to assess quality of life.
Timepoint [5] 409694 0
Four weeks post-treatment completion and two-month follow up

Eligibility
Key inclusion criteria
To be eligible for this study, patients will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM–5) and display difficulties falling asleep (as this is the target subtype of the THIM treatment), assessed via the following criteria:
• at least 30 minutes to fall asleep.
• The problem is present for > 3 nights per week for at least 3 months.
• The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
• A regular sleep phase between 10:00 PM and 8:00 AM.
Participants must also :
• Be aged 18 to 74 years.
• Fluent in English, as is a requirement to self-administer the treatments.
• Have reliable access to an internet-enabled smartphone and personal computer for the duration of the study.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• shift work.
• other known diagnoses of serious health conditions (diabetes, chronic pain, arthritis, chronic obstructive pulmonary disease, emphysema, heart disease, tinnitus, chronic bronchitis, high blood pressure, asthma, bipoloar).
• other known treated or untreated sleep disorder diagnoses (e.g., sleep apnea, restless legs syndrome), or scores on self-report questionnaires (STOP-BANG, IRLS) indicating the presence of potentially undiagnosed disorders.
• recent hypnotic medication or drug use (within 3 months).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation (4 participants per block).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311448 0
Charities/Societies/Foundations
Name [1] 311448 0
American Academy of Sleep Medicine Foundation
Country [1] 311448 0
United States of America
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
Sturt Rd,
Bedford Park South Australia, 5042
Country
Australia
Secondary sponsor category [1] 312844 0
None
Name [1] 312844 0
Address [1] 312844 0
Country [1] 312844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310921 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 310921 0
SALHN Office for Research
Corporate Services
Southern Adelaide Local Health Network
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 310921 0
Australia
Date submitted for ethics approval [1] 310921 0
Approval date [1] 310921 0
19/01/2022
Ethics approval number [1] 310921 0

Summary
Brief summary
The research project is testing two new home-based insomnia treatments. One treatment is a sleep wearable device called THIM, which has been developed to administer a treatment called Intensive Sleep Retraining. The other treatment is an online program called SHUTi (Sleep Health Using The Internet) that administers a brief version of cognitive behavioural therapy for insomnia. Patients who meet diagnostic criteria for insomnia and have sleep onset difficulties will be randomly allocated to one of the four groups: THIM by itself, SHUTi by itself, THIM and SHUTi combined, waitlist control group.
The study aims are to investigate:
1) the efficacy of THIM versus a waitlist control group for treating insomnia.
2) the efficacy of the combination versus all other treatments for treating insomnia.
3) the cost-benefits of remote therapies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119354 0
Dr Hannah Scott
Address 119354 0
Adelaide Institute for Sleep Health
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 119354 0
Australia
Phone 119354 0
+61882012767
Fax 119354 0
Email 119354 0
hannah.scott@flinders.edu.au
Contact person for public queries
Name 119355 0
Dr Hannah Scott
Address 119355 0
AISH:FCRE, Level 2A
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 119355 0
Australia
Phone 119355 0
+61882012767
Fax 119355 0
Email 119355 0
hannah.scott@flinders.edu.au
Contact person for scientific queries
Name 119356 0
Dr Hannah Scott
Address 119356 0
Adelaide Institute for Sleep Health
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 119356 0
Australia
Phone 119356 0
+61882012767
Fax 119356 0
Email 119356 0
hannah.scott@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, de-identified.
When will data be available (start and end dates)?
Within 1 year after publication, no end date determined.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator via email request (hannah.scott@flinders.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.