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Not yet recruiting NCT07425964

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

No phase Interventional Migraine Disorder Low Back Pain Chronic Pain Sleep Disorder (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep Hygiene Education.
Who it may be relevant to
Registry conditions: Migraine Disorder, Low Back Pain, Chronic Pain, Sleep Disorder (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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 daytim

Primary outcome measures

  • Change in Sleep Quality (PSQI Global Score) [Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)]
Secondary outcome measures (8)
  • 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]
  • Change in Temporal Summation of Pain (Pinprick Sensitivity Test) [Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)]
  • Change in PainDetect [Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)]
  • Change in Headache Impact (HIT-6) - for migraine participants only [Time frame: Baseline (Visit 1) to 4 weeks (Visit 2)]
  • Long-Term Maintenance of Sleep Hygiene Index, SHI [Time frame: 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)]
  • Long-Term Maintenance of PSQI [Time frame: 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)]
  • Long-Term Pain Intensity Measure - PainDetect [Time frame: 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07425964 · 20250034AAU · N-20250034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗