About this trial
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 insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.
Eligibility criteria
Qualifiers
Adults aged ≥ 18 years
Able to give informed online consent
Insomnia Severity Index ≥ 12
English fluency
Disqualifiers
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)
Trial design
Treatments tested in this trial
- SleepFix
- Sleep health Education modules