Digital sleep therapy to help people with fibromyalgia move more

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Oxford
  Oxford, United Kingdom Recruiting
• Oxford Centre for Integrative Neuroimaging
  Oxford, United Kingdom Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.