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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Bruce Matt, Indiana University
ClinicalTrials.gov Identifier:
NCT00394550
First received: October 30, 2006
Last updated: April 2, 2013
Last verified: April 2013

October 30, 2006
April 2, 2013
January 2002
December 2018   (final data collection date for primary outcome measure)
  • 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 ]
  • as measured by overnight polysomnogram:
  • Changes in minimum oxygen saturation
  • Changes in Respiratory Disturbance index
  • Changes in peak end-tidal carbon dioxide(CO2) level
  • Changes in mean end-tidal carbon dioxide(CO2) level
Complete list of historical versions of study NCT00394550 on ClinicalTrials.gov Archive Site
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 ]
overall category of airway obstruction on polysomnogram (e.g. normal, mild, moderate, severe obstructive sleep apnea)
Not Provided
Not Provided
 
Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty
Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Respiration Disorders
  • 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
  • No Intervention: control
    If laryngomalacia is found, then in the control group, no supraglottoplasty will be performed. Only the tonsils and adenoids will be removed.
  • Experimental: Treatment

    If laryngomalacia is found, then in the Treatment group, a supraglottoplasty with laser will be performed, as well as removal of the tonsils and adenoids.

    Intervention: supraglottoplasty with laser

    Interventions:
    • Procedure: supraglottoplasty with laser
    • Procedure: supraglottoplasty with laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
757
December 2018
December 2018   (final data collection date for primary outcome measure)

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.
Both
1 Year to 18 Years
Yes
Contact: Bruce H Matt, MD, MS 317-944-6670
Contact: Nashon Mays 317-944-6670
United States
 
NCT00394550
1011003593
Yes
Bruce Matt, Indiana University
Indiana University School of Medicine
Not Provided
Principal Investigator: Bruce H. Matt, MD, MS Indiana University School of Medicine
Indiana University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP