Sleep Hygiene Education to Improve Sleep in Chronic Migraine and Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAalborg University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Sleep Hygiene Education
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Sleep Hygiene EducationExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (Visit 1) to 4 weeks (Visit 2)Secondary outcomes
1
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.
Time frame
Baseline (Visit 1) to 4 weeks (Visit 2); Week 1; Week 2; Week 3; 3-month follow-up2
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.
Time frame
Baseline (Visit 1) to 4 weeks (Visit 2)3
Change in PainDetect
PainDetect assesses neuropathic and centrally mediated pain components. Higher scores indicate a higher likelihood of central sensitization.
Time frame
Baseline (Visit 1) to 4 weeks (Visit 2)4
Change in Headache Impact (HIT-6) - for migraine participants only
The HIT-6 assesses the functional impact of headaches. Higher scores indicate greater impairment.
Time frame
Baseline (Visit 1) to 4 weeks (Visit 2)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: