Inferior Turbinate Reduction in Pediatric Population Failing Tonsillectomy and Adenoidectomy for Sleep Disordered Breathing (Randomized, Prospective, Controlled Study)
| City: |
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Columbia |
| State: |
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Missouri |
| Zip Code: |
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65212 |
| Conditions: |
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Sleep Related Breathing Disorder - Upper Airway Resistance Syndrome - Obstructive Sleep Apnea |
| Purpose: |
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The question proposed by this study is one of treatment: To what extent does treatment of
nasal obstruction from enlarged inferior turbinates with cold ablation inferior turbinate
reduction in infants, children, and adolescents improve symptoms of obstructive sleep apnea,
sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing, and
upper airway resistance syndrome in patients that continue to have symptoms after
tonsillectomy and adenoidectomy.
The trial seeks to provide evidence that the treatment of inferior turbinates in patients
with continued symptoms of obstructive sleep apnea, sleep related breathing disorder,
snoring, disturbed sleeping, open mouth breathing, and upper airway resistance syndrome
after tonsillectomy and adenoidectomy will improve these symptoms and should be included in
the treatment paradigm for treatment of sleep related breathing disorders in infants,
children, and adolescents.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Patients that underwent tonsillectomy and adenoidectomy for obstructive sleep apnea,
sleep related breathing disorder, snoring, disturbed sleeping, open mouth breathing,
and upper airway resistance syndrome with persistent symptomatology.
2. Enlarged inferior turbinates with nasal obstruction (>25%).
3. Age 0-18 years.
4. Lack of improvement of obstructive sleep apnea symptoms after maximal medical
treatment with intranasal steroids in patients with symptoms of ARS and H2 blocker
medication in patients with symptoms of LPR.
Exclusion Criteria:
1. Previous adenotonsillar surgery or placement of tympanostomy tubes for recurrent
otitis media, tonsillitis, or sinusitis.
2. Patients with BMI > 97% for age and sex.
3. Patients with craniofacial abnormalities.
4. Patients with previous airway issues, anatomic variance from normal, mallampati class
III or IV, septal deviation, choanal stenosis, and nasal stenosis.
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| NCT ID: |
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NCT00936494 |
| Primary Contact: |
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Young S Paik, MD
Phone: 573-882-8173
Email: paiky@health.missouri.edu
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| Backup Contact: |
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Email: govarie@health.missouri.edu
Eliav Gov-Ari, MD
Phone: 573-882-8173
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| Location Contact: |
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Columbia, Missouri 65212
United States
Young Paik, MD
Email: paiky@health.missouri.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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