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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00394550
• Other study ID #: 1011003593
• Status: Terminated
• Phase: N/A
• Start date: January 2002
• Est. completion date: December 2019

Study information

• Verified date: January 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Laryngomalacia
• Respiration Disorders
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Riley Childrens' Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	as measured by overnight polysomnogram:		within one year of operation
Primary	Changes in minimum oxygen saturation		within one year of operation
Primary	Changes in Respiratory Disturbance index		within one year of operation
Primary	Changes in peak end-tidal carbon dioxide(CO2) level		within one year of operation
Primary	Changes in mean end-tidal carbon dioxide(CO2) level		within one year of operation
Secondary	overall category of airway obstruction on polysomnogram (e.g. normal, mild, moderate, severe obstructive sleep apnea)		within one year of operation