Fibromyalgia Clinical Trials

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Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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: * 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
United Kingdom
Oxford Centre for Integrative Neuroimaging
NOT_YET_RECRUITING
Oxford
University of Oxford
RECRUITING
Oxford
Contact Information
Primary
Amanda Wall, BSc MSc
amanda.wall@ndcn.ox.ac.uk
+44 1865 611450
Backup
Eoin Kelleher, MB BCh DPhil
eoin.kelleher@ndcn.ox.ac.uk
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 142
Treatments
Experimental: Digital Cognitive Behavioural Therapy for Insomnia
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
Active_comparator: Standard Care with Sleep Hygiene Education
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.
Related Therapeutic Areas
Sponsors
Leads: University of Oxford
Collaborators: Oxford University Hospitals NHS Trust

This content was sourced from clinicaltrials.gov