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Comparing Home-Based Digital Treatments for Insomnia.

A Randomized Controlled Trial Comparing Home-Based Intensive Sleep Retraining to Online CBT-I and The Combination for the Treatment of Chronic Insomnia Disorder.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000778785
Enrollment
105
Registered
2022-05-31
Start date
2022-08-01
Completion date
2024-12-16
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 s

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years
Healthy volunteers
No

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 28, 2026