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NCT05656365 · ClinicalTrials.gov registry record
Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders
A clinical trial of Obstructive Sleep Apnea and Sleep Disordered Breathing, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- 1,500
- Enrollment target
- 3
- Study locations
NCT05656365: Recruiting study of Obstructive Sleep Apnea and Sleep Disordered Breathing, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05656365 is a study of Obstructive Sleep Apnea and Sleep Disordered Breathing that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,500 participants, above the 212-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (608% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05656365, a study of Obstructive Sleep Apnea and Sleep Disordered Breathing, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 3
- Study locations
Study Summary
Background: Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) is the most common periodic fever syndrome of childhood. Symptoms can include swelling of the glands in the throat, mouth ulcers, and tonsillitis. Removal of the tonsils can stop the periodic flareups. But researchers do not know how PFAPA develops. In this natural history study, researchers will collect specimens and data from people with PFAPA to see what they might have in common. Objective: To collect blood and other specimens from people with PFAPA to learn more about the illness. Eligibility: People aged 1 month or older with symptoms of PFAPA or another tonsil disorder. Design: Participants will be screened. Their medical records will be reviewed. Researchers will ask about a family history of PFAPA. The following specimens may be collected: Blood. Blood will be drawn either from a needle inserted into a vein or from a prick in the finger or heel. Mucus and cells. A stick with soft padding on the tip may be rubbed inside the nostrils or mouth. Stool. Saliva. Tissue samples may be taken if participants are having surgery to remove the tonsils or adenoids. Participants having surgery may also have a nasopharyngeal wash; salt water will be squirted into the back of the throat and then sucked back out with a syringe. Most participants will provide specimens only once. They can do this in person at the clinic; they can also have their local health providers send specimens to the researchers. Some participants may have optional follow-up visits over 10 years.
Primary Outcome
To collect samples to understand the immunologic mechanisms and genetic and microbial risk factors for PFAPA and other tonsil disorders
Conditions Studied
Study Locations (3)
District of Columbia
- Children's National Medical Center - Washington D.C.
Indiana
- Indiana University School of Medicine - Indianapolis
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2038-12-31 |
What NCT05656365 shows while recruiting
NCT05656365 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 212-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (608% higher).
The record links to 5 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 0 interventions.
NCT05656365 reports a single indexed study location in District of Columbia, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT05656365 about?
NCT05656365 is a clinical study titled "Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders". Background: Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) is the most common periodic fever syndrome of childhood. Symptoms can include swelling of the glands in the throat, mouth ulcers, and tonsillitis. Removal of the tonsils can stop the periodic flareups. But r...
What is the current status of trial NCT05656365?
This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2023-05-23. Estimated completion is 2038-12-31.
What conditions does trial NCT05656365 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Sleep Disordered Breathing, Tonsillitis, Periodic Fever, Aphthous Stomatitis, Pharyngitis, And Cervical Adenitis (Pfapa), Tonsil Disorder.
Who is sponsoring clinical trial NCT05656365?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05656365 being conducted?
This trial has 3 study locations across District of Columbia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05656365's enrollment target sits among peer trials
1,500 5th of 155 higher than 151 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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.
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