Migraine DisorderNCT07425964
Sleep Hygiene Education to Improve Sleep in Chronic Migraine and Back Pain
A study testing Sleep Hygiene Education in people with Migraine Disorder and Low Back Pain, run by Aalborg University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorder, Low Back Pain, Chronic Pain
- What is being tested?
- Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Emma Hertel contact
About this study
Official title: 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:
Read more
- Does a four-week sleep hygiene education program improve sleep quality?
- 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
- Being tested
- Sleep Hygiene Education
- Keywords
- Sleep Quality, Sleep Hygiene, Pain Sensitivity
- Medical subject headings
- Migraine Disorders, Low Back Pain, Chronic Pain, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education | Experimental | 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. Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 1) to 4 weeks (Visit 2)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks (Visit 2) to 3-month post-intervention follow-up (remote)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kjær Petersen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425964
- Sponsor's protocol ID
- 20250034AAU
- Other IDs
- N-20250034
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kan Uddannelse i søvnhygiejne Forbedre søvnkvalitet for Patienter Med Kroniske Smerter?
- ClinicalTrials.gov ID
- NCT07425964
- Acronym / sponsor ID
- 20250034AAU
- Keywords
- Sleep Quality, Sleep Hygiene, Pain Sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a four-week sleep hygiene education program improve sleep quality?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education | Experimental | Behavioral: Sleep Hygiene EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene EducationThe 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. | Behavioural | Sleep Hygiene Education |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Hertel contact
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education in people with Migraine Disorder and Low Back Pain, run by Aalborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristian Kjær-Staal Petersen (+45 31697510, kkp@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality (PSQI Global Score) (time frame: Baseline (Visit 1) to 4 weeks (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.