InsomniaSleepFixNCT06114901
Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
A study testing SleepFix and Sleep health Education modules in people with Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- SleepFix and Sleep health Education modules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2025to 26 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Woolcock Institute of Medical Research
Sydney, New South Wales, 2037
About this study
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
- Being tested
- SleepFix, Sleep health Education modules
- Keywords
- CBTi, Digital CBTi, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepFixOther
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.
Sleep health Education modulesOther
Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sleep health Education modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 8 weeks
Workforce productivity
Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks.
Measured: 8 Weeks
Sleep medication usage
Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion26 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Online (digital), two-arm, open-label randomised clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woolcock Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Gordon, PhD, Principal investigator, Macquarie University, Woolcock Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114901
- Sponsor's protocol ID
- X23-0371
- Acronym
- SleepFix
- Status last verified
- Oct 2023
- First submitted
- 29 Oct 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06114901
- Acronym / sponsor ID
- SleepFix / X23-0371
- Conditions
- Insomnia
- Keywords
- CBTi, Digital CBTi, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Woolcock Institute of Medical ResearchUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 26 Oct 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Online (digital), two-arm, open-label randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention - SleepFix | Experimental | Other: SleepFixParticipants 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. |
| Control - Sleep Health Education modules | Active comparator | Other: Sleep health Education modulesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SleepFixSleepFix 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 | Intervention - SleepFix |
| Sleep health Education modulesThree Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality. | Other | Control - Sleep Health Education modules |
Primary outcome
Change in insomnia symptom severity change
Time frame: 8 weeks
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 secondary outcomes
Change in sleep-wake metrics
Time frame: 8 weeks
Daytime symptoms of fatigue
Time frame: 8 weeks
Change in anxiety scores
Time frame: 8 weeks
Change in depressive symptom scores
Time frame: 8 weeks
Change in quality of life scores
Time frame: 8 weeks
Treatment usability
Time frame: 8 weeks
Workforce productivity
Time frame: 8 Weeks
Sleep medication usage
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Gordon, PhD principal investigator
Macquarie University, Woolcock Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepFix and Sleep health Education modules in people with Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Rahimi, PhD (0061298053146, matthew.rahimi@mq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insomnia symptom severity change (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.