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Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

Key facts

Where
Sydney, AustraliaSee the site

Where in Australia

  • Woolcock Institute of Medical ResearchSydney, AustraliaContact: Matthew Rahimi, PhDNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Woolcock Institute of Medical Research
Trial code
NCT06114901
Record updated
16 July 2024
Original description
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.Read full original descriptionShow less

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.

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: 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); Serious medical and/or psychiatric illnesses/disorders; Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am); Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc); Pregnant women.

ClinicalTrials.gov NCT06114901