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

NCT ID: NCT00394550

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2019-12-31

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).

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.

Conditions

Sleep Apnea, Obstructive; Respiration Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

If laryngomalacia is found, then in the control group, no supraglottoplasty will be performed. Only the tonsils and adenoids will be removed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

supraglottoplasty with laser

Intervention Type: 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

supraglottoplasty with laser

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

supraglottoplasty with laser

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Bruce Matt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce H. Matt, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Riley Childrens' Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1011003593

Identifier Type: -

Identifier Source: org_study_id