NCT07492420 · Amenity Health, Inc.
MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
What this study is about
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- St Louis, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations