Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394550
Status:
TERMINATED
Last Update Posted:
2022-01-25
First Post:
2006-10-30
Brief Title:
Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia the Role of Laser Supraglottoplasty
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia the Role of Laser Supraglottoplasty
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient institutional support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childs progress Additional laboratory tests or drawing of blood is not routine in this procedure but may be performed as dictated by your childs medical conditions
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 childs progress Additional laboratory tests or drawing of blood is not routine in this procedure but may be performed as dictated by your childs medical conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None