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Not yet recruiting Not applicable NCT06114901

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

No applicable phase (e.g. observational)
Conditions: Insomnia

Sponsor: Woolcock Institute of Medical Research

trial.available_in: БГ
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.
Who can participate
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
Locations 1
Australia (1)
Woolcock Institute of Medical Research
Sydney , New South Wales
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.02.2025
Completion date
26.10.2028
Registry ID
NCT06114901
Source
anzctr
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