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Sleep therapy may ease fibromyalgia pain and boost movement

NCT ID NCT07465991

Symptom relief Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a digital sleep therapy program (Sleepio) can improve quality of life and movement in 142 adults with fibromyalgia who also have trouble sleeping. Participants will use the program at home for 10 weeks and wear devices to track sleep and activity. Researchers will compare results to standard care with sleep advice to see if better sleep reduces pain and fear of movement.

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

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * Willing and able to provide informed consent for participation in the study * Male or female, aged 18 years or above * Clinical diagnosis of fibromyalgia or chronic widespread pain * Concomitant insomnia, frequent nighttime waking, or early morning waking * Self-reported difficulties with concentration or memory * Reliable internet access (required to access digital intervention) Exclusion Criteria: * Poor understanding of English * Known neurological conditions (other than depression or anxiety) likely to independently affect pain assessment results (e.g., peripheral diabetic neuropathy) * Major neuropsychiatric disorder (bipolar disorder, schizophrenia, or psychotic spectrum disorders) * Epilepsy * Cognitive impairment, dementia, or neurodegenerative disorder * Recent surgery (within past 3 months) or planned surgery during study period * Current night-time shift work or planned night-time shift work during study period * Diagnosed sleep disorders including sleep apnea, restless leg syndrome, circadian rhythm disorder, or parasomnia * Taking prescribed sleep medications on more than 2 nights in the past 2 weeks * Currently receiving other psychological therapy for insomnia * Pregnant or lactating

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Conditions

The condition(s) this trial relates to.

Chronic Pain fibromyalgia insomnia Kinesiophobia

As listed by the trial registrant

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

Fibromyalgia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oxford Centre for Integrative Neuroimaging

    NOT_YET_RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • University of Oxford

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

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