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Treating insomnia symptoms using the THIM sleep tracking device.

A clinical trial of the efficacy of THIM-administered Intensive Sleep Re-training for treating chronic insomnia symptoms.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000850178
Enrollment
12
Registered
2019-06-17
Start date
2020-03-01
Completion date
2021-09-06
Last updated
2022-03-21

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

Conditions

None listed

Brief summary

This project will be the first to test the effectiveness of the sleep wearable device called THIM for administering Intensive Sleep Retraining in the home environment. We will also examine the ability of THIM to provide effective and affordable treatment for insomnia, improve individual sleep health and general well-being. We predict that THIM-administered Intensive Sleep Retraining intervention condition will demonstrate: • increased total sleep time and sleep efficiency; • reduced sleep onset latency and time awake after sleep onset; • improvements in daytime functioning measures Compared to the Sleep Hygiene Control condition at post-treatment and two-month follow up time points.

Interventions

The intervention in this clinical trial is THIM-administered Intensive Sleep Retraining. This behavioural treatment protocol requires the patient to fall asleep and be woken up shortly after sleep onset on multiple occasions over the course of one four-hour treatment session. This treatment will occur in the patient's home environment beginning around their typical bedtime. THIM is a small, light-weight device worn on the index finger of the dominant hand like a ring. It is calibrated using an a

The intervention in this clinical trial is THIM-administered Intensive Sleep Retraining. This behavioural treatment protocol requires the patient to fall asleep and be woken up shortly after sleep onset on multiple occasions over the course of one four-hour treatment session. This treatment will occur in the patient's home environment beginning around their typical bedtime. THIM is a small, light-weight device worn on the index finger of the dominant hand like a ring. It is calibrated using an accompanying smartphone application via Bluetooth, which is also used to retrieve the data. THIM will administer Intensive Sleep Retraining by detecting when the patient has fallen asleep and promptly waking them up with a high intensity alarm vibration. Participants will be instructed to wake up at their typical wake up time following the Intensive Sleep Retraining session. Sleep hygiene instructions will also be provided in paper form by the principle researcher, including typical instructions about maintaining a consistent sleep schedule, limiting caffeine intake in the afternoon, and creating a relaxing bedroom environment. Adherence will be monitored via THIM data linkage, participant sleep diary, and data from a watch-like actigraphy device (measures movement to estimate sleep and wakefulness) to be worn on the wrist throughout data collection. On the intervention night, both the intervention and control group will undergo ambulatory polysomnography (PSG) recording to objectively measure physiological changes associated with sleep (brain waves, etc.). This will provide an additional measure of treatment adherence. Participants will be set up with a portable PSG device by sleep technicians in the sleep laboratory, but participants will be able to return home to undergo either THIM-administered Intensive Sleep Retraining or the control 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 80 Years
Healthy volunteers
No

Inclusion criteria

1. Sleep diary data which indicates difficulties initiating sleep (>30 minute latency to sleep) at least three times in the one-week screening assessment period. 2. Sleep and daytime functioning questionnaire scores which indicate insomnia symptoms: o Insomnia Severity Index score > 15 o Pittsburgh Sleep Quality Index score > 5 o Daytime Feelings and Functioning Scale score > 12 o Flinders Fatigue Scale > 8 o Dysfunctional Beliefs About Sleep Scale score > 3 o Pre-Sleep Arousal Scale score > 23 3. Self-report that these difficulties have persisted for >3 months.

Exclusion criteria

• English language difficulties that might preclude fully informed consent. • Taking medication which interferes with sleep • Receiving other forms of sleep treatment • Self-report sleep disorders other than Insomnia (e.g., Sleep Apnoea, Restless Legs Syndrome) • Serious physical or mental health conditions • Pregnancy/lactation • Current smoker • Excessive caffeine consumption (greater than or equal to 300mg per day) • Excessive alcohol consumption (greater than or equal to 10 standard drinks per week) • Recent trans-meridian travel (over at least 2 time zones) or shift work (within last 2 months)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026