| City: |
|
Indianapolis |
|
State:
|
|
IN |
| Zip Code: |
|
46202 |
| Conditions: |
|
Sleep Apnea, Obstructive - Respiration Disorders |
| Purpose: |
|
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).
|
| Study summary: |
|
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. |
| 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. |
|
|
|
| Study is available at: |
|
Riley Childrens' Hospital
Indianapolis, IN 46202
United States
Primary Contact:
Shelley Bizila
Email: resrisk@iupui.edu
Phone: 317-274-8289
Secondary Contact:
Bruce H Matt, MD, MS
Phone: 317-944-6670 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|