- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06114901
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial (SleepFix)
October 29, 2023 updated by: Woolcock Institute of Medical Research
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
558
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Rahimi, PhD
- Phone Number: 0061298053146
- Email: matthew.rahimi@mq.edu.au
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2037
- Woolcock Institute of Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
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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.
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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.
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Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia symptom severity
Time Frame: 8 weeks
|
Insomnia symptom severity will be measure by Insomnia Severity Index (ISI)
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep-wake metrics
Time Frame: 8 weeks
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Sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency will be measured using a sleep diary and subjective sleep quality using the The Pittsburgh Sleep Quality Index questionnaire.
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8 weeks
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Daytime symptoms of fatigue
Time Frame: 8 weeks
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Daytime symptoms of fatigue with Flinders Fatigue Scale questionnaire
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8 weeks
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Anxiety
Time Frame: 8 weeks
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The General Anxiety Disorder-7 will be used to measure anxiety levels
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8 weeks
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Depression
Time Frame: 8 weeks
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The Patient Health Questionnaire-8 is a brief questionnaire used to assess the severity of depression
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8 weeks
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Quality of life
Time Frame: 8 weeks
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The EuroQol five-dimensional (EQ-5D) will be used to measure quality of life.
EQ-5D is a well-validated, generic instrument for measuring health related quality of life.
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8 weeks
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Treatment usability
Time Frame: 8 weeks
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The USE questionnaire is a survey that examines four dimensions of usability: useful- ness, ease of use, ease of learning, and satisfaction.
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8 weeks
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Workforce productivity
Time Frame: 8 Weeks
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Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks.
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8 Weeks
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Sleep medication usage
Time Frame: 8 weeks
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Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks.
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christopher Gordon, PhD, Macquarie University, Woolcock Institute of Medical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 10, 2023
Primary Completion (Estimated)
October 26, 2028
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)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 29, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on SleepFix
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-
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