Status:
NOT_YET_RECRUITING
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Lead Sponsor:
Woolcock Institute of Medical Research
Conditions:
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating i...
Eligibility Criteria
Inclusion
- Adults aged ≥ 18 years
- Able to give informed online consent
- Insomnia Severity Index ≥ 12
- English fluency
- Access to a smartphone and willingness/proficiency to use a mobile application
Exclusion
- Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)
- Serious medical and/or psychiatric illnesses/disorders
- Previously diagnosed or suspected/high-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome
- Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)
- Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)
- Pregnant women
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 26 2028
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT06114901
Start Date
February 1 2025
End Date
October 26 2028
Last Update
July 16 2024
Active Locations (1)
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1
Woolcock Institute of Medical Research
Sydney, New South Wales, Australia, 2037