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NCT Number: NCT07425964

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

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

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Key information

Conditions

Migraine Disorder Back Pain Behavior Brain Diseases Central Nervous System Diseases Chronic Pain Dyssomnias Headache Disorders Headache Disorders, Primary Health Behavior Low Back Pain Mental Disorders Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder (Disorder) Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Sleep Quality (PSQI Global Score)

    Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)

    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.

Secondary outcomes

  1. Change in Sleep Hygiene Behaviors (Sleep Hygiene Index, SHI)

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

    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.

  2. Change in Temporal Summation of Pain (Pinprick Sensitivity Test)

    Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)

    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.

  3. Change in PainDetect

    Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)

    PainDetect assesses neuropathic and centrally mediated pain components. Higher scores indicate a higher likelihood of central sensitization.

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

    Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)

    The HIT-6 assesses the functional impact of headaches. Higher scores indicate greater impairment.

  5. Long-Term Maintenance of Sleep Hygiene Index, SHI

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

    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.

  6. Long-Term Maintenance of PSQI

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

    Assessed via an online questionnaire evaluating whether changes in PSQI persist three months after the intervention period. Higher scores indicate poorer quality of sleep.

  7. Long-Term Pain Intensity Measure - PainDetect

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

    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.

  8. Long-Term Maintenance of Headache Impact (HIT-6) - for migraine participants only

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

    Assessed via an online questionnaire evaluating whether changes in HIT-6 persist three months after the intervention period. Higher scores indicate greater impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hertel

CONTACT

[email protected]

Kristian Kjær-Staal Petersen

CONTACT

[email protected]

+45 31697510

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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