NCT06114901

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 558 (estimated)
• Sponsor: Woolcock Institute of Medical Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
OTHER	SleepFix	SleepFix mobile application uses Sleep Retraining Therapy (SRT) which aims to reduce excess time spent in bed and reset sleep by matching time in bed (minimum of five and a half hours) to total sleep time (TST). There are four stages to the dBTi application and participants will progress based on completion of each stage. At the commencement of SleepFix application, participants enter sleep and bedtime data into the smartphone application for baseline referencing. These data are used to determine the sleep therapy based on a pre-determined algorithm that calculates optimum sleep efficiency.
OTHER	Sleep health Education modules	Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-12-01
• Completion: 2028-10-26
• First posted: 2023-11-02
• Last updated: 2024-07-16

Locations

1 site across 1 country: Australia