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

NCT07425964 | Not Yet Recruiting DMC

• 2 other identifiers: 20250034AAUN-20250034
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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)

Keywords

Sleep Quality; Sleep Hygiene; Pain Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Quality (PSQI Global Score)

  Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire summarized into a global sleep quality score (0-21). Higher scores indicate poorer sleep quality. The primary outcome is the change in PSQI global score after four weeks of sleep hygiene education.

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

Secondary Outcomes (8)

• Change in Sleep Hygiene Behaviors (Sleep Hygiene Index, SHI)

  Baseline (Visit 1) to 4 weeks (Visit 2); Week 1; Week 2; Week 3; 3-month follow-up

• Change in Temporal Summation of Pain (Pinprick Sensitivity Test)

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

• Change in PainDetect

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

• Change in Headache Impact (HIT-6) - for migraine participants only

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

• Long-Term Maintenance of Sleep Hygiene Index, SHI

  4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)

Study Arms (1)

Sleep Hygiene Education

EXPERIMENTAL

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.

Behavioral: Sleep Hygiene Education

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.

Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Aalborg University: lead

MeSH Terms

Conditions

Migraine Disorders; Low Back Pain; Chronic Pain; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Health Behavior; Behavior

Central Study Contacts

Kristian Kjær-Staal Petersen

CONTACT

+45 31697510; kkp@hst.aau.dk

Emma Hertel

CONTACT

eh@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-01