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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06114901
Registration number
NCT06114901
Ethics application status
Date submitted
29/10/2023
Date registered
2/11/2023
Titles & IDs
Public title
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
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Scientific title
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
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Secondary ID [1]
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X23-0371
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Universal Trial Number (UTN)
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Trial acronym
SleepFix
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insomnia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - SleepFix
Other interventions - Sleep health Education modules
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.
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 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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in insomnia symptom severity change
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Assessment method [1]
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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.
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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Change in sleep-wake metrics
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Assessment method [1]
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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.
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Timepoint [1]
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8 weeks
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Secondary outcome [2]
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Daytime symptoms of fatigue
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Assessment method [2]
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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.
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Timepoint [2]
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8 weeks
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Secondary outcome [3]
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Change in anxiety scores
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Assessment method [3]
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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.
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Timepoint [3]
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8 weeks
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Secondary outcome [4]
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Change in depressive symptom scores
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Assessment method [4]
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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.
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Timepoint [4]
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8 weeks
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Secondary outcome [5]
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Change in quality of life scores
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Assessment method [5]
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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).
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Timepoint [5]
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8 weeks
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Secondary outcome [6]
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Treatment usability
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Assessment method [6]
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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.
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Timepoint [6]
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8 weeks
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Secondary outcome [7]
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Workforce productivity
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Assessment method [7]
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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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Timepoint [7]
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8 Weeks
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Secondary outcome [8]
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Sleep medication usage
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Assessment method [8]
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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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Timepoint [8]
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8 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/02/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/10/2028
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Actual
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Sample size
Target
558
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Sydney
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Recruitment postcode(s) [1]
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2037 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06114901
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christopher Gordon, PhD
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Address
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Macquarie University, Woolcock Institute of Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Matthew Rahimi, PhD
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Address
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Country
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Phone
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0061298053146
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06114901