Not Yet RecruitingNot Applicable

Sleep Hygiene Education to Improve Sleep in Chronic Migraine and Back Pain

100 participantsStarted 2026-02

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Pregnancy * Drug addiction, defined as the use of cannabis, opioids, or other drugs * Malignant comorbidity (e.g., cancer) * 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. * Use of unstable sleep-modulating pharmacological treatment (e.g., melatonin, tricyclic antidepressants) * Diagnosed sleep disorder (e.g., insomnia, narcolepsy, sleep apnoea) * Night-shift work * Initiation of any new therapy during the study period * The subject is assessed as unable to engage in the necessary cooperation required by the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Sleep Quality (PSQI Global Score)

Timeframe: Baseline (Visit 1) to 4 weeks (Visit 2)

Trial details

NCT IDNCT07425964

SponsorAalborg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Kristian Kjær-Staal Petersen

+45 31697510 kkp@hst.aau.dk

View on ClinicalTrials.gov More Migraine Disorder trials