Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04936321 · ClinicalTrials.gov registry record · NA
Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial
A NA study of Insomnia and Migraine Disorders, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- NA
- Development phase
- 224
- Enrollment target
- 1
- Study location
NCT04936321: Active NA study of Insomnia and Migraine Disorders, sponsored by Seattle Children's Hospital.
NCT04936321 is a NA study of Insomnia and Migraine Disorders that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 224 participants, above the 169-participant average among 151 other Insomnia trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04936321, a NA study of Insomnia and Migraine Disorders, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 224 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The 7-item Insomnia Severity Index (ISI) measures severity of insomnia symptoms. Total scores above 8 on the ISI indicate clinically significant insomnia in adult and adolescent samples.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2025-03 |
| Phase | NA |
What the registry record for NCT04936321 still lists
NCT04936321 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 151 other Insomnia trials with a reported enrollment target (33% higher).
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.
NCT04936321 reports a single indexed study location in Washington.
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.
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).
Who is sponsoring clinical trial NCT04936321?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04936321's enrollment target sits among peer trials
224 32nd of 151 higher than 120 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatments for Insomnia in Veterans With PTSD
RECRUITING · NA
-
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
RECRUITING · NA
-
mPATH for Low-income Older Adults
RECRUITING · NA
-
Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD
RECRUITING · NA
-
Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study
RECRUITING · NA
-
Treatments in Women Veterans With Insomnia and PTSD
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02706561 · 224 participants · NA
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
- NCT04140344 · 224 participants · NA
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
- NCT04915183 · 224 participants · Phase 2
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
- NCT05519878 · 224 participants · NA
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI