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

NCT07425964 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-23

No results posted yet for this study

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

Conditions

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

Interventions

BEHAVIORAL

Sleep Hygiene Education

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.

Sponsors & Collaborators

  • Aalborg University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07425964 on ClinicalTrials.gov