MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
Recruiting now · Not applicable
Conditions studied: Mild Obstructive Sleep Apnea
In brief
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
Key facts
- Study ID
- NCT07492420
- Run by
- Amenity Health, Inc.
- People needed
- 35
- Starts
- 2026-03-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis with mild obstructive sleep apnea (AHI 5-14.9)
- PSG or HST performed within last 24 months
- Individuals aged 18 or older
- Must routinely sleep on a standard mattress and must be able to accommodate the width of the MedCline Sleep System (30")
- 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
- Ability to provide written informed consent in accordance with IRB principles
- Must be stable on any medications for at least 3 months prior to the date of consent
You may not qualify if…
- Diagnosis of moderate to severe OSA (AHI >15) or central sleep apnea
- Has undergone surgical procedures for sleep apnea within the last six months
- Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes.
- Chronic pain or musculoskeletal disorders, e.g., spinal deformities, scoliosis, kyphosis, back injuries, spinal compressions, or injuries that may affect their ability to sleep comfortably in a lateral position
- Pregnant or planning to become pregnant during study period
- Any conditions or circumstances that require frequent night-time awakenings (e.g., nocturia, caregiving responsibilities, or other health issues)
- Unable or unwilling to use the MedCline Sleep System as required by the study protocol
- Currently using substances or medications known to significantly alter sleep architecture or respiratory function (e.g., sedatives, narcotics, or alcohol dependency)
Where it is running
- Clayton Sleep Institute — St Louis, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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