Status:
COMPLETED
Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Medtronic Xomed, Inc.
ResMed Foundation
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea.
Detailed Description
Obstructive sleep apnea (OSA), frequently associated with disruptive snoring, is a prevalent disorder which is increasingly recognized by health care providers and lay people alike as an important fac...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Age \>18 yrs
- AHI 5-30
- Tonsil size \<50% of airway
- No anatomically fixed nasal stenosis
- BMI = 32 kg/m2 EXCLUSION CRITERIA
- 1\. The presence of a concomitant untreated primary sleep disorder (restless legs syndrome, narcolepsy, idiopathic hypersomnia) 2. Severe daytime sleepiness (history of sleep-related motor vehicle or occupational accident) 3. Moderate to severe pulmonary disease (FEV1 \<50% pred) 4. Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis) 5. Significant cardiac disease (LVEF\<50%, moderate to severe valvular disease) 6. Uncontrolled hypertension \>180/110 7. Renal disease (Scr \> 2.5) 8. Allergy to local anesthetics used for implantation procedure. 9. Pregnant or nursing women
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00263770
Start Date
December 1 2005
End Date
October 1 2007
Last Update
May 20 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905