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Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty
This study is currently recruiting participants.
Verified by Indiana University, January 2009
First Received: October 30, 2006   Last Updated: January 27, 2009   History of Changes
Sponsored by: Indiana University School of Medicine
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00394550
  Purpose

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).


Condition Intervention
Sleep Apnea, Obstructive
Respiration Disorders
Procedure: supraglottoplasty with laser
Procedure: laser supraglottoplasty

MedlinePlus related topics: Choking Sleep Apnea Tonsils and Adenoids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • as measured by overnight polysomnogram: [ Time Frame: within one year of operation ] [ Designated as safety issue: No ]
  • Changes in minimum oxygen saturation [ Time Frame: within one year of operation ] [ Designated as safety issue: No ]
  • Changes in Respiratory Disturbance index [ Time Frame: within one year of operation ] [ Designated as safety issue: No ]
  • Changes in peak end-tidal carbon dioxide(CO2) level [ Time Frame: within one year of operation ] [ Designated as safety issue: No ]
  • Changes in mean end-tidal carbon dioxide(CO2) level [ Time Frame: within one year of operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall category of airway obstruction on polysomnogram (e.g. normal, mild, moderate, severe obstructive sleep apnea) [ Time Frame: within one year of operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 757
Study Start Date: January 2002
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control: No Intervention
If laryngomalacia is found, then in the control group, no supraglottoplasty will be performed. Only the tonsils and adenoids will be removed.
Treatment: Experimental
If laryngomalacia is found, then in the Treatment group, a supraglottoplasty will be performed, as well as removal of the tonsils and adenoids.
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: laser supraglottoplasty
laser excision of laryngomalacia (floppy tissue) on one side of the supraglottis

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) and tonsils removed (if not previously performed), direct laryngoscopy (looking in the throat) and bronchoscopy (inspection of the lungs with a long tube-like device down the throat), and randomization (½ will be treated further, ½ will be observed) into treatment and no-treatment arms if your child is diagnosed with laryngomalacia. After starting general anesthesia (putting patient to sleep for procedure), the surgeon will perform direct laryngoscopy (look at the throat and voice box) and bronchoscopy (look at the entrance to the lungs [trachea or windpipe]). If your child is diagnosed with laryngomalacia (flopping of the tissue around the voice box, potentially causing obstruction or blockage), 50% will undergo a further treatment (laser supraglottoplasty, or removal of tissue at the entrance of the voice box) and 50% will be observed. The decision to treat or not treat will be random, as is customary for prospective research trials. All children (both treatment arms will receive a 3 week treatment of a medicine (a proton pump inhibitor) to reduce the level of stomach acid and prevent potential exposure of the larynx (voice-box) to stomach acid. If your child does not have laryngomalacia, no further treatment on the larynx (voice-box) will be performed. Next, adenotonsillectomy will be performed as is common for the Otolaryngologist performing the procedure. Postoperatively, a sleep study will be performed (identical to the preoperative study) ideally 3-6 months after surgery, (but up to one year after) to monitor your child's progress. Additional laboratory tests or drawing of blood is not routine in this procedure, but may be performed as dictated by your child's medical conditions.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394550

Contacts
Contact: Bruce H Matt, MD, MS 317-274-6670
Contact: Patricia Gatlin 317-274-6670

Locations
United States, Indiana
Riley Childrens' Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shelley Bizila     317-274-8289     resrisk@iupui.edu    
Principal Investigator: Bruce H Matt, MD, MS            
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Bruce H. Matt, MD, MS Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Bruce H. Matt, MD )
Study ID Numbers: 0101-29
Study First Received: October 30, 2006
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00394550     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
laryngomalacia
supraglottoplasty
Tonsillectomy
Adenoidectomy
obstructive sleep apnea
Laser
Polysomnogram
airway obstruction

Study placed in the following topic categories:
Ibuprofen
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Laryngomalacia
Anesthetics
Sleep Disorders
Dyssomnias
Narcotics
Codeine
Sleep Disorders, Intrinsic
Signs and Symptoms
Anti-Bacterial Agents
Proton Pump Inhibitors
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Airway Obstruction
Analgesics
Acetaminophen
Ethanol

Additional relevant MeSH terms:
Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 07, 2009