MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy (NCT07492420) | Clinical Trial Compass
RecruitingNot Applicable
MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
United States35 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of AHI on Apnea-Hypopnea Index scale
Timeframe: Night 1 to Night 8
2
Reduction of ODI on Oxygen Desaturation Index Scale
. 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)