Status:
WITHDRAWN
Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Henry Ford Health System
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
17+ years
Brief Summary
The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft pala...
Detailed Description
Purpose: To determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft palate and uvula length...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Documented obstructive sleep apnea (with central apneas of the total number of apneas plus hypopneas)
- Able to complete all forms in English and follow-up appointments
- Willing to undergo 3 home sleep studies; and markedly hypertrophic (3+ or 4+) tonsils
- Tonsil size of 3+ or 4+ corresponds to tonsils that occupy more than 50% of the space between the tonsillar fossa (side of the throat) and midline
Exclusion
- No craniofacial abnormality
- No history of COPD, untreated psychological disorder, other sleep disorder, alcohol or drug abuse
- Body mass index \<35 kg/m2
- Unable to tolerate other treatments for obstructive sleep apnea
- Soft palate length \> 4 cm
- Uvula length \> 2 cm
- No significant nasal obstruction
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02204696
Start Date
December 1 2010
End Date
July 1 2015
Last Update
December 2 2015
Active Locations (1)
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1
Keck Hospital of USC
Los Angeles, California, United States, 90033