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

Kan Uddannelse i søvnhygiejne Forbedre søvnkvalitet for Patienter Med Kroniske Smerter?

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 Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Chronic Pain; Migraine Disorder; Sleep Disorder (Disorder)
• Intervention / Treatment: Behavioral: Sleep Hygiene Education

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Hertel; Email: eh@hst.aau.dk
• Study Contact Backup: Name: Kristian Kjær-Staal Petersen; Phone Number: +45 31697510; Email: kkp@hst.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Hygiene Behaviors (Sleep Hygiene Index, SHI)	Sleep hygiene behaviors are measured using the Sleep Hygiene Index (SHI), which assesses engagement in behaviors that negatively impact sleep. Higher scores reflect poorer sleep hygiene. Changes across time points will be assessed.	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)	Temporal summation is assessed using a standardized pinprick protocol on the volar forearm. Participants provide pain ratings for a single stimulus and for the last of 10 consecutive stimuli. The outcome is the change in temporal summation response.	Baseline (Visit 1) to 4 weeks (Visit 2)
Change in PainDetect	PainDetect assesses neuropathic and centrally mediated pain components. Higher scores indicate a higher likelihood of central sensitization.	Baseline (Visit 1) to 4 weeks (Visit 2)
Change in Headache Impact (HIT-6) - for migraine participants only	The HIT-6 assesses the functional impact of headaches. Higher scores indicate greater impairment.	Baseline (Visit 1) to 4 weeks (Visit 2)
Long-Term Maintenance of Sleep Hygiene Index, SHI	Assessed via an online questionnaire evaluating whether changes in SHI scores persist three months after the intervention period. Higher scores reflect poorer sleep hygiene adherence.	4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)
Long-Term Maintenance of PSQI	Assessed via an online questionnaire evaluating whether changes in PSQI persist three months after the intervention period. Higher scores indicate poorer quality of sleep.	4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)
Long-Term Pain Intensity Measure - PainDetect	Assessed via an online questionnaire evaluating whether changes in PainDetect scores persist three months after the intervention period. Higher scores indicate a higher likelihood of central sensitization.	4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)
Long-Term Maintenance of Headache Impact (HIT-6) - for migraine participants only	Assessed via an online questionnaire evaluating whether changes in HIT-6 persist three months after the intervention period. Higher scores indicate greater impairment.	4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Quality; Sleep Hygiene; Pain Sensitivity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Back Pain; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Migraine Disorders; Chronic Pain; Sleep Initiation and Maintenance Disorders; Low Back Pain; Sleep Wake Disorders; Sleep Hygiene
• Other Study ID Numbers: 20250034AAU; N-20250034 (Other Identifier: The North Denmark Region Committee on Health Research Ethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No