The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus no-therapy for six weeks. Up to 200 participants will be enrolled, in order to randomized n=102.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
eXciteOSA
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Delta Waves
Colorado Springs, Colorado, United States
Florida Lung & Sleep Associates
Lehigh Acres, Florida, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
Respiratory event index
The difference in the delta-REI (baseline to follow-up) between arms
Time frame: Six weeks
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Clayton Sleep Institute
St Louis, Missouri, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States