Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty
Stopped early · Not applicable
Conditions studied: Sleep Apnea, Obstructive, Respiration Disorders
In brief
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 (blockage of breathing while sleeping). The purpose of this study is to determine which is the best treatment for children with obstructive sleep apnea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway).
Key facts
- Study ID
- NCT00394550
- Run by
- Indiana University
- People needed
- 160
- Starts
- 2002-01-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2022-01-25
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Riley Childrens' Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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