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

NCT06114901 | Not Yet Recruiting

• 1 other identifier: X23-0371
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

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

Keywords

CBTi; Digital CBTi; Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in insomnia symptom severity change

  Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 28) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.

  8 weeks

Secondary Outcomes (8)

• Change in sleep-wake metrics

  8 weeks

• Daytime symptoms of fatigue

  8 weeks

• Change in anxiety scores

  8 weeks

• Change in depressive symptom scores

  8 weeks

• Change in quality of life scores

  8 weeks

Study Arms (2)

Intervention - SleepFix

EXPERIMENTAL

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.

Other: SleepFix

Control - Sleep Health Education modules

ACTIVE COMPARATOR

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.

Other: Sleep health Education modules

Interventions

SleepFix 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.

Intervention - SleepFix

Sleep health Education modules 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.

Control - Sleep Health Education modules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead

Study Sites (1)

Woolcock Institute of Medical Research

Sydney, New South Wales, 2037, Australia

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Christopher Gordon, PhD

  Macquarie University, Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Rahimi, PhD

CONTACT

0061298053146; matthew.rahimi@mq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research staff and Principal Chief Investigator will not be blinded to the study as they will be managing the online study directly which will lend itself to knowing which groups participants are allocated to. All other Investigators including data analysts will be blinded throughout the course of the trial and analysis of primary and secondary outcomes. Participants will not be blinded as they will know what treatment they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Online (digital), two-arm, open-label randomised clinical trial

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 2, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 26, 2028
• Last Updated: July 16, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)