Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive

In brief

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.

Key facts

Study ID

NCT00263770

Run by

Mayo Clinic

People needed

64

Starts

2005-12-01

Expected to finish

2007-10-01

Last updated by the study team

2011-05-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 yrs
• AHI 5-30
• Tonsil size <50% of airway
• No anatomically fixed nasal stenosis
• BMI = 32 kg/m2 EXCLUSION CRITERIA
• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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