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SleepFix app aims to ease back pain by fixing sleep

NCT ID NCT05846087

Symptom relief Sponsor: Woolcock Institute of Medical Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a mobile app called SleepFix that helps people with chronic low back pain and insomnia improve their sleep. Over 100 adults used either the app or received sleep education for 3 weeks. The goal was to see if better sleep could reduce how much pain interferes with daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SleepFix mobile app (sleep retraining therapy)
What this could lead to
If it works, this could offer a simple, app-based way to improve both sleep and pain interference for people with chronic low back pain.
What could go wrong
This is a small, completed trial with 106 participants. The results may not apply to everyone, and the app may not work for those with certain other pain conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

106 people

The number who actually took part.

Started

Sep 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged ≥ 18 years. 2. Chronic low back pain (pain in lower back region which has been present for 3 months or more). 3. Able to give informed online consent. 4. Insomnia Severity Index Score \>10. 5. English fluency. 6. Access to a smartphone and willingness/proficiency to use a mobile app for healthcare. Exclusion Criteria: 1. Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column. 2. Shift-workers. Regular work that falls outside the hours between 7am and 6pm. 3. Trans-meridian travel to a destination with \>2 hours' time-difference (within last 7-days and will subjective reports that they are not experiencing jet lag). 4. Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia). 5. Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism). 6. Sleep devices (e.g. CPAP) 7. Currently receiving psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT). 8. Professional driver or operate heavy machinery;

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Conditions

The condition(s) this trial relates to.

insomnia Low Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low-back pain Insomnia

Contacts and locations

Locations

  • Woolcock Institute of Medical Research

    Sydney, New South Wales, 2037, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.