CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
sleep retraining therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05846087
NCT05846087N/ACompleted
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Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study

Woolcock Institute of Medical Research·interventional·Posted May 6, 2023·Updated Dec 2, 2025

In Brief

A clinical study evaluating sleep retraining therapy and sleep health education modules for Chronic Low-back Pain and Insomnia. Completed, enrolled 106 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement. Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low-back Pain, Insomnia
CountriesAustralia
CollaboratorsCooperative Research Centre for Alertness, Safety and Productivity, University of Sydney

Timeline

N/ACompletedFinished
202420252026
First PostedMay 6, 2023
Enrollment StartSep 13, 2023
Primary CompletionOct 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.2 years ago

Interventions

sleep retraining therapybehavioral

Sleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed.

sleep health education modulesother

educational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks.