Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06114901




Registration number
NCT06114901
Ethics application status
Date submitted
29/10/2023
Date registered
2/11/2023
Date last updated
14/05/2024

Titles & IDs
Public title
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Scientific title
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Secondary ID [1] 0 0
X23-0371
Universal Trial Number (UTN)
Trial acronym
SleepFix
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in insomnia symptom severity change
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Change in sleep-wake metrics
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Daytime symptoms of fatigue
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Change in anxiety scores
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Change in depressive symptom scores
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Change in quality of life scores
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Treatment usability
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Workforce productivity
Timepoint [7] 0 0
8 Weeks
Secondary outcome [8] 0 0
Sleep medication usage
Timepoint [8] 0 0
8 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/10/2028
Actual
Sample size
Target
558
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2037 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06114901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Gordon, PhD
Address 0 0
Macquarie University, Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Matthew Rahimi, PhD
Address 0 0
Country 0 0
Phone 0 0
0061298053146
Fax 0 0
Email 0 0
matthew.rahimi@mq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06114901