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

NCT ID: NCT06114901

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-10-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention - SleepFix

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.

Group Type: EXPERIMENTAL

SleepFix

Intervention Type: OTHER

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.

Control - Sleep Health Education modules

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.

Group Type: ACTIVE_COMPARATOR

Sleep health Education modules

Intervention Type: OTHER

Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woolcock Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

Macquarie University, Woolcock Institute of Medical Research

Locations

Woolcock Institute of Medical Research

Sydney, New South Wales, Australia

Countries

Australia

Central Contacts

Matthew Rahimi, PhD

Role: CONTACT

matthew.rahimi@mq.edu.au

0061298053146

Other Identifiers

X23-0371

Identifier Type: -

Identifier Source: org_study_id