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Online sleep therapy for adults with fibromyalgia and poor sleep

Tests an online sleep program for adults with fibromyalgia who sleep badly.

Key facts

Who runs it
University of Oxford
Where
United Kingdom2 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia
Status
Recruiting
People taking part
142 people, planned
Started
1 Jan 2026
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Digital Cognitive Behavioural Therapy for Insomnia
  • Sleep Hygiene Education Materials
Record updated
12 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fibromyalgia or chronic widespread pain who also have trouble sleeping. It tests a digital sleep therapy program called Sleepio against standard care with sleep advice materials.

Age
18 years or older
Sex
Male or female
Disease stage
A doctor's diagnosis of fibromyalgia or chronic widespread pain. You must also have insomnia, wake often at night, or wake too early in the morning. You must also report problems with concentration or memory.
Earlier treatment
You cannot join if you took prescribed sleep medicines on more than 2 nights in the past 2 weeks. You cannot join if you are now getting another talking therapy for insomnia.

Main reasons for not taking part

  • Poor understanding of English, or no reliable internet access
  • Nerve or brain conditions that could affect pain tests, epilepsy, dementia or memory decline, or bipolar disorder, schizophrenia or psychosis
  • Diagnosed sleep disorders such as sleep apnea, restless leg syndrome, body clock disorder or parasomnia
  • Surgery in the past 3 months or planned during the study, or current or planned night shift work
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Recent surgery (within past 3 months) or planned surgery during study period
  • Taking prescribed sleep medications on more than 2 nights in the past 2 weeks
  • Currently receiving other psychological therapy for insomnia
  • 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
  • Diagnosed sleep disorders including sleep apnea, restless leg syndrome, circadian rhythm disorder, or parasomnia
  • Poor understanding of English
  • Current night-time shift work or planned night-time shift work during study period
  • Pregnant or lactating

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this clinical trial is to learn if a digital sleep therapy program (digital Cognitive Behavioural Therapy for Insomnia or dCBT-I) works to improve quality of life and movement in adults with fibromyalgia who also have trouble sleeping. The main questions it aims to answer are:

Read full original descriptionShow less

* Does digital sleep therapy improve quality of life for people with fibromyalgia? * Does digital sleep therapy improve sleep quality? * Does better sleep help reduce fear of movement and increase physical activity, assessed in a virtual reality (VR) environment?

Researchers will compare digital sleep therapy (called 'Sleepio') to standard care with sleep advice materials.

Participants will:

* Use the Sleepio program at home for 10 weeks (6 sessions, 20 minutes each) * Wear a sleep monitoring device at home in bed for several nights at the start and after 3 months * Wear an activity watch for 1 week to track movement at the start and after 3 months * Complete questionnaires about pain, sleep, mood, and daily activities at the start, 3 months, and 6 months * Visit the study centre twice for assessments that include:

* Pain sensitivity testing * A virtual reality game that measures how they move and make decisions * Recording of simple exercises like marching and squats

Participation in the study lasts about 6 months.

The 2 groups in the trial

  • Digital Cognitive Behavioural Therapy for InsomniaTreatment being tested

    Participants in this arm will receive access to Sleepio, a digital cognitive behavioural therapy for insomnia (dCBT-I) program. The intervention consists of 6 automated sessions (approximately 20 minutes each) delivered over 10 weeks via web browser or smartphone app. Sessions include evidence-based cognitive and behavioral interventions, sleep hygiene education, time-in-bed restriction, and relaxation exercises. Participants have access to a daily online sleep diary, an online community, and library of resources. SMS reminders will be sent to encourage compliance, and participants will receive telephone or video check-ins from a study investigator at weeks 1, 3, and 6. Participants will also be provided with written sleep hygiene materials from Versus Arthritis, and continue to receive their standard NHS care

    Treatment: Digital Cognitive Behavioural Therapy for Insomnia and Sleep Hygiene Education Materials

  • Standard Care with Sleep Hygiene EducationExisting treatment, for comparison

    Participants in this arm will be provided with written sleep hygiene materials from Versus Arthritis, and continue to receive their standard NHS care. Materials include information booklets and video resources on managing fibromyalgia and improving sleep. Participants do not receive access to the Sleepio digital CBT-I program but continue with routine clinical care during the study period.

    Treatment: Sleep Hygiene Education Materials

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
Plain-language title
Online sleep therapy for adults with fibromyalgia and poor sleepGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
12 March 2026