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New treatment option for Mild Obstructive Sleep Apnea
Official title MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
ClinicalTrials.gov ID: NCT07492420
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.