Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
Sleep Apnea, Obstructive
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Active Comparator
Sham Comparator
Positive airway pressure (PAP)
outpatient surgical procedure
Sham surgery
which is air delivered by a mask worn over the nose during sleep
where small fabric rods are inserted into the soft palate (the fleshy portion of the roof of the mouth) to stiffen the tissues.
an outpatient surgical procedure identical to #2 except that no rods are inserted into the soft palate.