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ACTIVE NOT RECRUITING NA

Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial

NCT04936321 · View on ClinicalTrials.gov ↗

Study Summary

Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

Interventions

  • BEHAVIORAL Internet-delivered CBT for Insomnia
  • BEHAVIORAL Internet-delivered CBT for Pain Management
  • BEHAVIORAL Internet-delivered Sleep Education

Study Locations (1)

Washington

  • Seattle Children's Hospital — Seattle

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2021-10-01
Est. Completion 2025-03
Phase NA

Sponsor

Seattle Children's Hospital

127 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04936321

The ClinicalTrials.gov registry entry for NCT04936321 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions — of which Internet-delivered CBT for Insomnia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04936321 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04936321 about?

NCT04936321 is a clinical study titled "Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial". Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache...

What is the current status of trial NCT04936321?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 224 participants. The study started on 2021-10-01. Estimated completion is 2025-03.

What conditions does trial NCT04936321 study?

This clinical trial studies the following conditions: Insomnia, Migraine Disorders, Headache Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04936321?

The interventions under investigation include: Internet-delivered CBT for Insomnia (BEHAVIORAL), Internet-delivered CBT for Pain Management (BEHAVIORAL), Internet-delivered Sleep Education (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04936321?

This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04936321 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial