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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

Reduction of AHI on Apnea-Hypopnea Index scale

Timeframe: Night 1 to Night 8

Reduction of ODI on Oxygen Desaturation Index Scale

Timeframe: Night 1 to Night 8

NCT IDNCT07492420

SponsorAmenity Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-01

Matthew Uhles

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)