NCT06351839 Sleep Well Despite Persistent Pain Symptoms
| NCT ID | NCT06351839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tromso |
| Condition | Insomnia Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The "Sleep-Well" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality. Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital. Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression. The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later.
Eligibility Criteria
Inclusion Criteria: * Patients who, after clinical examination at University hospital of Northern Norway (UNN) fill the criteria for a chronic non-malignant pain diagnosis according to ICD-10. * Satisfy criteria for a comorbid insomnia * Both first-time referrals and former referred patients. Exclusion Criteria: * A comorbid drug abuse diagnosis (ICD-10) * An ongoing compensation and/or insurance case related to a health issue, illness or treatment * Drug treatment using \>100 morphine equivalents * Participation in other group-based treatments at the UNN Pain Department or the Physical Outpatient Medical Clinic (must be completed before inclusion)
Contact & Investigator
Oddgeir Friborg, PhD
PRINCIPAL INVESTIGATOR
UiT The Arctic University of Norway
Frequently Asked Questions
Who can join the NCT06351839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Insomnia Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06351839 currently recruiting?
Yes, NCT06351839 is actively recruiting participants. Contact the research team at oddgeir.friborg@uit.no for enrollment information.
Where is the NCT06351839 trial being conducted?
This trial is being conducted at Tromsø, Norway.
Who is sponsoring the NCT06351839 clinical trial?
NCT06351839 is sponsored by University of Tromso. The principal investigator is Oddgeir Friborg, PhD at UiT The Arctic University of Norway. The trial plans to enroll 106 participants.
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