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NCT Number: NCT06114901

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woolcock Institute of Medical Research

Sydney, New South Wales, 2037, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SleepFix

Other

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 modules

Other

Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in sleep-wake metrics

    Time frame: 8 weeks

    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.

  2. Daytime symptoms of fatigue

    Time frame: 8 weeks

    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.

  3. Change in anxiety scores

    Time frame: 8 weeks

    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.

  4. Change in depressive symptom scores

    Time frame: 8 weeks

    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.

  5. Change in quality of life scores

    Time frame: 8 weeks

    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).

  6. Treatment usability

    Time frame: 8 weeks

    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.

  7. Workforce productivity

    Time frame: 8 Weeks

    Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks.

  8. Sleep medication usage

    Time frame: 8 weeks

    Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Rahimi, PhD

CONTACT

[email protected]

0061298053146

Sponsors and collaborators

Lead sponsor

Woolcock Institute of Medical Research

Other

Registry information

Acronym: SleepFix

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Nov 2, 2023
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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