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

Sponsor
Aalborg University
Study ID
NCT07425964
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Low Back Pain
  • Migraine Disorder
  • Sleep Disorder (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sleep Hygiene Education — BEHAVIORAL
    The intervention consists of a structured and standardized sleep hygiene education program delivered in a single in-person session. Participants receive verbal instruction and written materials outlining evidence-based recommendations for improving sleep habits. The content focuses on establishing consistent bedtimes and wake times, creating a good sleep environment, reducing evening exposure to stimulants and electronic devices, developing calming nighttime routines, and adopting healthy daytime behaviors. Participants implement these strategies independently for four weeks.

Study Details

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 Dates

First listed
Feb 23, 2026
Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sleep Hygiene Education
    Participants receive a structured sleep hygiene education program during the first study visit, including verbal instructions and written materials covering consistent sleep routines, sleep environment optimization, evening habits, and reduction of stimulants and screen use. Participants are asked to apply the recommendations in daily life for four weeks and complete weekly online check-ins. At the second visit, they repeat questionnaires and sensory testing to evaluate changes from baseline.

Primary Outcome Measure

Change in Sleep Quality (PSQI Global Score) [ Time Frame: Baseline (Visit 1) to 4 weeks (Visit 2) ]

Central Contacts

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