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Better sleep, less pain? new study tests sleep hygiene for migraine and back pain

NCT ID NCT07425964

Symptom relief Sponsor: Aalborg University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a single session of sleep hygiene education can improve sleep quality and reduce pain in 100 adults with migraine or chronic lower back pain. Participants will learn healthy sleep habits and follow them for four weeks, tracking changes through questionnaires and pain sensitivity tests. There is no comparison group—each person serves as their own control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sleep hygiene education
What this could lead to
If it works, this could point toward a simple, non-drug way to improve sleep and reduce pain for people with chronic pain conditions.
What could go wrong
This is a small, early study with no comparison group, so results may be due to chance or the placebo effect. The education is brief and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome insomnia Low Back Pain migraine disorder sleep disorder Sleep Hygiene sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pain Low back pain Migraine disorder Sleep disorder (disorder)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.