Plain-English translation of NCT07465991 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing whether Sleepio, a digital cognitive behavioural therapy program for insomnia, can help people with fibromyalgia improve their sleep and become more physically active. The study is based on the idea that poor sleep and pain create a difficult cycle: when you sleep poorly, your pain gets worse, and when pain increases, sleep becomes even harder. By improving sleep with this online program, researchers hope to break that cycle and help people feel less pain and have more energy to move and exercise.
People with fibromyalgia often struggle with both severe pain and poor sleep, which fuel each other and make the condition worse. Current treatments don't always address both problems together, and many patients say that sleep problems prevent them from exercising—which is one of the most helpful treatments for fibromyalgia. This trial is testing whether fixing the sleep problem first could help unlock the ability to be more active and reduce pain.
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If you join this study, you will be randomly assigned to either receive the online sleep program or standard care with written sleep hygiene tips. If you receive the online program, you'll complete 6 sessions of about 20 minutes each over 10 weeks using a web browser or smartphone app, keep a daily sleep diary, and receive check-in calls or video visits from a researcher at weeks 1, 3, and 6. Throughout the study, you'll continue your regular NHS care. The entire study lasts several months, and researchers will measure your sleep quality, pain levels, and how much physical activity you're doing.
AI-generated summary from trial data · Jun 6, 2026 · Not medical advice
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