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

NCT00394550 | Terminated DMC

• 1 other identifier: 1011003593
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

laryngomalacia; supraglottoplasty; Tonsillectomy; Adenoidectomy; obstructive sleep apnea; Laser; Polysomnogram; airway obstruction

Outcome Measures

Primary Outcomes (5)

• as measured by overnight polysomnogram:

  within one year of operation

• Changes in minimum oxygen saturation

  within one year of operation

• Changes in Respiratory Disturbance index

  within one year of operation

• Changes in peak end-tidal carbon dioxide(CO2) level

  within one year of operation

• Changes in mean end-tidal carbon dioxide(CO2) level

  within one year of operation

Secondary Outcomes (1)

• overall category of airway obstruction on polysomnogram (e.g. normal, mild, moderate, severe obstructive sleep apnea)

  within one year of operation

Study Arms (2)

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 with laser will be performed, as well as removal of the tonsils and adenoids. Intervention: supraglottoplasty with laser

Procedure: supraglottoplasty with laser

Interventions

supraglottoplasty with laser PROCEDURE

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

Treatment

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Riley Childrens' Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Respiration Disorders; Laryngomalacia; Airway Obstruction

Interventions

Lasers

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cartilage Diseases; Musculoskeletal Diseases; Laryngeal Diseases; Otorhinolaryngologic Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Respiratory Insufficiency

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Bruce H. Matt, MD, MSc

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: November 1, 2006
• Study Start: January 1, 2002
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

US (1)