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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Other: SleepFix; Other: Sleep health Education modules

• Study Type: Interventional
• Enrollment (Estimated): 558
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Rahimi, PhD; Phone Number: 0061298053146; Email: matthew.rahimi@mq.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2037
      • Woolcock Institute of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 determine the sleep therapy based on a pre-determined algorithm that calculates optimum sleep efficiency.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workforce productivity	Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks.	8 Weeks
Sleep medication usage	Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks.	8 weeks
Change in sleep-wake metrics	Sleep- wake metrics will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with seven component scores derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.	8 weeks
Daytime symptoms of fatigue	The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from "not at all" = 0 to "extremely" = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue.	8 weeks
Change in anxiety scores	The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety over the previous 2 weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.	8 weeks
Change in depressive symptom scores	The Patient Health Questionnaire-8 is an 8-item self-reported measure of depressive symptoms over the past 2 weeks. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.	8 weeks
Change in quality of life scores	The EuroQol five-dimensional (EQ-5D) is a self-reported questionnaire which assesses 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and overall health. The 5 dimensions range from "1 = indicating no problem" - "5 = indicating unable to/extreme problems" and the overall score from 0 (worst health state imaginable) to 100 (best health state imaginable).	8 weeks
Treatment usability	The System Usability Scale (SUS) questionnaire is a 10-item survey that examines four dimensions of usability: useful- ness, ease of use, ease of learning, and satisfaction. It is scored out of a 100; scores closer to 100 means excellent usability while scores closer to 0 means worse usability.	8 weeks

Collaborators and Investigators

• Sponsor: Woolcock Institute of Medical Research
• Investigators: Principal Investigator: Christopher Gordon, PhD, Macquarie University, Woolcock Institute of Medical Research

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 26, 2028

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Insomnia; CBTi; Digital CBTi
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: X23-0371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No