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Online sleep therapy may ease migraines in teens

NCT ID NCT04936321

Symptom relief Sponsor: Seattle Children's Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests whether online cognitive-behavioral therapy (CBT) for insomnia, combined with CBT for pain, can reduce headaches and improve sleep in adolescents aged 11-17 who have both migraine and insomnia. Participants receive internet-delivered programs focusing on sleep hygiene, pain coping skills, and activity pacing. The goal is to find effective self-management tools that can prevent migraine-related disability from continuing into adulthood.

What this could mean

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

Active substance
internet-delivered cognitive-behavioral therapy for insomnia and pain management
What this could lead to
If successful, this could offer an effective self-management approach for teens with migraine and insomnia, potentially breaking the cycle of chronic headaches into adulthood.
What could go wrong
This is a relatively small trial testing behavioral interventions, which may not work for everyone. Results may not apply to teens with other sleep disorders or serious health conditions.

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

224 people

The number who actually took part.

Started

Oct 2021

Finished

May 2026

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

11 to 17 years

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: * 11-17 years old * Headache present for at least three months and insomnia symptoms for the past month * Access to the Internet on any web-enabled device Exclusion Criteria: * Non-English speaking * Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy) * Unable to read at 5th grade level or complete surveys independently * A serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)

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Conditions

The condition(s) this trial relates to.

Headache headache disorder insomnia migraine disorder Pain

As listed by the trial registrant

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

Headache disorders Insomnia Migraine disorders

Contacts and locations

Locations

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

More trials for these conditions

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