Digital sleep therapy to help people with fibromyalgia move more
Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
NA · University of Oxford · NCT07465991
This trial tests whether the Sleepio digital sleep program helps adults with fibromyalgia and insomnia sleep better, feel less afraid to move, and be more physically active.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oxford (other) |
| Locations | 2 sites (Oxford and 1 other locations) |
| Trial ID | NCT07465991 on ClinicalTrials.gov |
What this trial studies
Adults with fibromyalgia and insomnia will be assigned to use the Sleepio digital CBT-I program at home for 10 weeks (six 20-minute sessions) or receive standard sleep hygiene materials. Participants will wear a sleep monitor in bed and an activity watch at baseline and three months, and complete questionnaires on pain, sleep, and mood. The study uses a virtual reality environment to measure fear of movement and its link to sleep and activity. Outcomes in the digital therapy group will be compared with the usual-care group to see if improving sleep reduces fear of movement and increases physical activity.
Who should consider this trial
Good fit: Adults aged 18 and over with a clinical diagnosis of fibromyalgia or chronic widespread pain who have insomnia symptoms, self-reported concentration or memory difficulties, and reliable internet access are ideal candidates.
Not a fit: People with major neuropsychiatric disorders, significant neurological conditions (other than depression or anxiety), epilepsy, major cognitive impairment, recent or planned surgery, current night-shift work, or other diagnosed sleep disorders are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this could improve sleep quality, reduce fear of movement, and increase daily physical activity, leading to better overall quality of life for people with fibromyalgia.
How similar studies have performed: Traditional CBT-I and some digital CBT-I programs have improved insomnia and shown benefits in chronic pain populations, but effects specifically on fear of movement and objective activity in fibromyalgia are less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oxford and 1 other locations
- Oxford Centre for Integrative Neuroimaging — Oxford, United Kingdom (NOT_YET_RECRUITING)
- University of Oxford — Oxford, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Ben Seymour, PhD — University of Oxford
- Study coordinator: Amanda Wall, BSc MSc
- Email: amanda.wall@ndcn.ox.ac.uk
- Phone: +44 1865 611450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, fibromyalgia, CBT-I, Cognitive behavioural therapy for insomnia, fear of movement, insomnia, actigraphy, virtual reality