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

NCT00394550 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-01-25

No results posted yet for this study

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 (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).

Conditions

  • Sleep Apnea, Obstructive
  • Respiration Disorders

Interventions

PROCEDURE

supraglottoplasty with laser

Polysomnogram, fiberoptic flexible laryngoscopy, adenotonsillectomy, direct laryngoscopy, bronchoscopy, laser supraglottoplasty, general anesthesia, a proton-pump inhibitor ibuprofen, acetaminophen with codeine without alcohol, or other narcotic containing medication, antibiotic, possible use of other analgesics per anesthesia None of these procedures are "new" or experimental. Our investigation pertains to a broader use of the laser supraglottoplasty to include children with obstructive sleep apnea and laryngomalacia, as opposed to the more traditional use of laser supraglottoplasty for only severe laryngomalacia in young children

PROCEDURE

supraglottoplasty with laser

laser excision of laryngomalacia (floppy tissue) on one side of the supraglottis

Sponsors & Collaborators

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Bruce H. Matt, MD, MSc · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00394550 on ClinicalTrials.gov