Status:
TERMINATED
Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Sleep Apnea, Obstructive
Respiration Disorders
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnea (bl...
Detailed Description
If you agree to have your child be in the study, you will do the following things: you are consenting to your child having the adenoid (tissue similar to lymph nodes, found in the back of the throat)...
Eligibility Criteria
Inclusion
- 1 year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor.
Exclusion
- prior laser supraglottoplasty, prior adenoidectomy prior tonsillectomy, stridor with cyanosis or apnea, severe respiratory distress, recurrent pneumonia (x3), Laryngeal cyst, vocal cord (VC) Paralysis, airway vascular malformation, neoplasm, subglottic hemangioma, paradoxical vocal cord (VC) motion, posterior glottic stenosis, glottic webs, discoordinate pharyngolaryngomalacia, or refusal to participate.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00394550
Start Date
January 1 2002
End Date
December 1 2019
Last Update
January 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Riley Childrens' Hospital
Indianapolis, Indiana, United States, 46202