NCT07425964Not yet recruiting
Sleep Hygiene Education to Improve Sleep in Chronic Migraine and Back Pain
Kan Uddannelse i søvnhygiejne Forbedre søvnkvalitet for Patienter Med Kroniske Smerter?
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether sleep hygiene education can improve sleep quality and reduce pain in adults with migraine and/or chronic lower back pain. Poor sleep is common in people with chronic pain and may worsen symptoms. Improving sleep may help break this cycle. The main questions this study aims to answer are: 1. Does a four-week sleep hygiene education program improve sleep quality? 2. Does improved sleep lead to reduced pain intensity and changes in pain sensitivity? This study does not include a comparison group. Each participant serves as their own comparison by completing the same tests before and after the sleep hygiene program. Participants will: * Attend two study visits lasting 30-60 minutes, one at the beginning and one after four weeks * Complete questionnaires about sleep, pain, mood, and quality of life at both visits * Undergo pain sensitivity testing using light pinprick stimulations on the forearm * Receive individual sleep hygiene education and written materials to use at home for four weeks * Complete a short weekly online check-in about sleep habits and pain * Complete a three-month follow-up questionnaire about sleep habits, sleep quality, and pain
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Aalborg University
- Diseases
- Migraine
- NCT number
- NCT07425964
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Feb 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug addiction, defined as the use of cannabis, opioids, or other drugs
- Neurological conditions affecting cognition (e.g., multiple sclerosis, epilepsy, dementia, previous stroke/transient cerebral ischemia)
- Intake of acute headache medication on ≥15 days/month for simple analgesics/NSAIDs or ≥10 days/month for triptans, ergotamine, opioids, or combinations thereof over 3 months.
- Initiation of any new therapy during the study period
Other illness
- Malignant comorbidity (e.g., cancer)
- Diagnosed sleep disorder (e.g., insomnia, narcolepsy, sleep apnoea)
Other
- Pregnancy
- Use of unstable sleep-modulating pharmacological treatment (e.g., melatonin, tricyclic antidepressants)
- Night-shift work
- The subject is assessed as unable to engage in the necessary cooperation required by the study
Who the study is looking for
- Chronic back pain (average pain VAS ≥ 3) AND/OR Migraine (migraine or tension headaches ≥15 days per month with ≥8 days being migraine)
- Lasting ≥3 months
- Adults ≥18 years old
- Read, speak, and understand Danish
- Willing to implement sleep hygiene for four weeks
- Digital competencies (sufficient to answer questionnaires online)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.