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

Not yet recruitingNot applicableNCT07425964
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Kan Uddannelse i søvnhygiejne Forbedre søvnkvalitet for Patienter Med Kroniske Smerter?
Conditions
Interventions
  • Behavioral: Sleep Hygiene Education
Sponsor
Aalborg University
Start date
2026-02
Primary completion
2028-12
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07425964