Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SleepFix, Sleep health Education modules.
- Who it may be relevant to
- Registry conditions: Insomnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 determin - 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.
Primary outcome measures
- Change in insomnia symptom severity change [Time frame: 8 weeks]
Secondary outcome measures (8)
- Change in sleep-wake metrics [Time frame: 8 weeks]
- Daytime symptoms of fatigue [Time frame: 8 weeks]
- Change in anxiety scores [Time frame: 8 weeks]
- Change in depressive symptom scores [Time frame: 8 weeks]
- Change in quality of life scores [Time frame: 8 weeks]
- Treatment usability [Time frame: 8 weeks]
- Workforce productivity [Time frame: 8 Weeks]
- Sleep medication usage [Time frame: 8 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Woolcock Institute of Medical Research — Sydney
Identifiers
NCT: NCT06114901 · X23-0371