An interventional study of Sleep Hygiene Education in Migraine Disorder, Low Back Pain and Chronic Pain, sponsored by Aalborg University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Aalborg University · Not applicable, Interventional, and Treatment
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:
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:
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Aalborg University is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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.
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)
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-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Assessed via an online questionnaire evaluating whether changes in HIT-6 persist three months after the intervention period. Higher scores indicate greater impairment.
Time frame: 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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