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

Starting soon · Not applicable

Conditions studied: Migraine Disorder, Low Back Pain, Chronic Pain, Sleep Disorder (Disorder)

In brief

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

Key facts

Study ID

NCT07425964

Run by

Aalborg University

People needed

100

Starts

2026-02-01

Expected to finish

2028-12-01

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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