MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
Amenity Health, Inc.
Summary
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
Description
OSA is a common sleep disorder characterized by partial or complete obstruction of the upper airway during sleep that leads to intermittent pauses in breathing (apneas) or shallow breathing (hypopneas). These interruptions can cause fragmented sleep, leading to daytime fatigue, cognitive impairments, and other health issues. Addressing mild OSA early is important, as it can progress to more severe forms if left untreated. OSA severity is measured using the Apnea-Hypopnea Index (AHI), which counts the number of apneas and hypopneas per hour of sleep. Estimates suggest that mild OSA, defined by…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis with mild obstructive sleep apnea (AHI 5-14.9) 2. PSG or HST performed within last 24 months 3. Individuals aged 18 or older 4. Must routinely sleep on a standard mattress and must be able to accommodate the width of the MedCline Sleep System (30") 5. Must be in overall good health, with no significant medical conditions that would interfere with the study procedures or the ability to sleep safely using the MedCline Sleep System 6. Ability to provide written informed consent in accordance with IRB principles 7. Must be stable on any medications for at least 3…
Interventions
- DeviceMedCline Sleep System
The MedCline Sleep System is an at-home positional therapy device to be placed on a bed surface.
Location
- Clayton Sleep InstituteSt Louis, Missouri