RecruitingNot ApplicableNCT07492420
MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
Sponsor
Amenity Health, Inc.
Enrollment
35 participants
Start Date
Mar 1, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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
Exclusion Criteria8
- 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)
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Interventions
DEVICEMedCline Sleep System
The MedCline Sleep System is an at-home positional therapy device to be placed on a bed surface.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07492420