Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form in accordance with IRB principles 7. Must be stable on any medications for at least 3 months prior to the date of consent Who Should NOT Join This Trial: 1. Diagnosis of moderate to severe OSA (AHI \>15) or central sleep apnea 2. Has undergone surgical procedures for sleep apnea within the last six months 3. Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes. 4. 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 5. Pregnant or planning to become pregnant during study period 6. Any conditions or circumstances that require frequent night-time awakenings (e.g., nocturia, caregiving responsibilities, or other health issues) 7. Unable or unwilling to use the MedCline Sleep System as required by the study protocol 8. Currently using substances or medications known to significantly alter sleep architecture or respiratory function (e.g., sedatives, narcotics, or alcohol dependency) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 months prior to the date of consent Exclusion Criteria: 1. Diagnosis of moderate to severe OSA (AHI \>15) or central sleep apnea 2. Has undergone surgical procedures for sleep apnea within the last six months 3. Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes. 4. 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 5. Pregnant or planning to become pregnant during study period 6. Any conditions or circumstances that require frequent night-time awakenings (e.g., nocturia, caregiving responsibilities, or other health issues) 7. Unable or unwilling to use the MedCline Sleep System as required by the study protocol 8. Currently using substances or medications known to significantly alter sleep architecture or respiratory function (e.g., sedatives, narcotics, or alcohol dependency)

Treatments Being Tested

DEVICE

MedCline Sleep System

The MedCline Sleep System is an at-home positional therapy device to be placed on a bed surface.

Locations (1)

Clayton Sleep Institute
St Louis, Missouri, United States