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NCT06114901 | NOT YET RECRUITING | Insomnia

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

Woolcock Institute of Medical Research

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 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.

Condition or disease

Insomnia

Intervention/treatment

SleepFix

Sleep health Education modules

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 558 participants
Masking : DOUBLE
Masking Description : The research staff and Principal Chief Investigator will not be blinded to the study as they will be managing the online study directly which will lend itself to knowing which groups participants are allocated to. All other Investigators including data analysts will be blinded throughout the course of the trial and analysis of primary and secondary outcomes. Participants will not be blinded as they will know what treatment they receive.
Primary Purpose : TREATMENT
Official Title : Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Actual Study Start Date : 2025-02-01
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2028-10-26

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

Location Details

NCT06114901

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Australia, New South Wales

Woolcock Institute of Medical Research

Sydney, New South Wales, Australia, 2037