An interventional study of supraglottoplasty with laser and supraglottoplasty with laser in Sleep Apnea, Obstructive and Respiration Disorders, sponsored by Indiana University School of Medicine. Terminated at 1 site in United States. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 160 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
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Exclusion Criteria:
If laryngomalacia is found, then in the control group, no supraglottoplasty will be performed. Only the tonsils and adenoids will be removed.
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
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
laser excision of laryngomalacia (floppy tissue) on one side of the supraglottis
as measured by overnight polysomnogram:
Time frame: within one year of operation
Changes in minimum oxygen saturation
Time frame: within one year of operation
Changes in Respiratory Disturbance index
Time frame: within one year of operation
Changes in peak end-tidal carbon dioxide(CO2) level
Time frame: within one year of operation
Changes in mean end-tidal carbon dioxide(CO2) level
Time frame: within one year of operation
overall category of airway obstruction on polysomnogram (e.g. normal, mild, moderate, severe obstructive sleep apnea)
Time frame: within one year of operation
Ran from Jan 2002 to primary completion in Dec 2019, 215 months.
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This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Indiana University School of Medicine