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

Royal Prince Alfred Hospital

Status: Not yet enrolling

Conditions: Insomnia

Treatments: Other: SleepFix; Other: Sleep health Education modules

Study type: Interventional

Funder types: Other

Identifiers

NCT06114901

X23-0371

Details and patient eligibility

About

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.

Enrollment: 558 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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558 participants in 2 patient groups

Intervention - SleepFix

Experimental group

Description:

Participants will get access to a webpage and video which will show participants information about the dBTi SleepFix mobile application. This information will explain application download, usage concepts and frequently asked questions (FAQ). The intervention webpage will continue to be available for the participants throughout the intervention period for reference if necessary and be only accessible by this group. Participants will also be sent an email and/or text message with a direct link to iOS or Google play app stores to download the "SleepFix" mobile application. They will be provided a unique alphanumeric access code and instructed to enter this code to access the app program. Participants will be able to commence therapy immediately upon app onboarding.

Treatment:

Other: SleepFix

Control - Sleep Health Education modules

Active Comparator group

Description:

The participant will receive a link to three Sleep Health Education modules bi-weekly. All participants in the control group will gain access to the SleepFix mobile application upon completing their control period.

Treatment:

Other: Sleep health Education modules