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Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty

Sponsored by Indiana University

Phase Quota
Phase N/A

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).

Study Start Date: January 2002

Estimated Completion Date: December 2018

Specialties: Pediatrics: Pediatric Otolaryngology Pulmonology: Apnea/Sleep Disorders Otolaryngology: Larynx/Trachea/Airway,Peds Otolaryngology

Interventions

  • Procedure: supraglottoplasty with laser
  • Procedure: laser supraglottoplasty

Inclusion criteria

  • 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 criteria

  • 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

Study Locations And Contact Information

  • Riley Childrens Hospital, Indianapolis Indiana

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