MedCline positional therapy for mild obstructive sleep apnea

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

This tests whether the MedCline Sleep System helps adults with mild obstructive sleep apnea reduce breathing interruptions and sleep better by encouraging side‑sleeping.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amenity Health, Inc. (Industry-sponsored)
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT07492420 on ClinicalTrials.gov

What this trial studies

The MedCline Sleep System is a positional therapy device intended to reduce supine sleep and promote lateral sleeping in adults with mild OSA. Adults with an AHI of 5–14.9 and a recent PSG or home sleep test will be enrolled and asked to use the device with follow‑up sleep measurements. Outcome measures include changes in AHI and ODI and patient‑reported sleep symptoms, with monitoring for device safety and tolerability. Participants must be 18 or older, able to fit the device on a standard mattress, and free of moderate/severe OSA or significant cardiopulmonary or musculoskeletal conditions.

Who should consider this trial

Good fit: Ideal candidates are adults 18+ with mild OSA (AHI 5–14.9), a PSG or HST within 24 months, who routinely sleep on a standard mattress and can tolerate a positional sleep system.

Not a fit: Patients with moderate to severe OSA (AHI >15), central sleep apnea, recent sleep apnea surgery, significant cardiac or respiratory disease, or inability to use the device due to mattress size or pain are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could reduce breathing interruptions and daytime symptoms for adults with mild OSA who prefer a non‑CPAP option.

How similar studies have performed: Positional therapy has helped many people with positional mild OSA reduce AHI in prior studies, though effectiveness varies by device and long‑term adherence can be limited.

Eligibility criteria

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)

Where this trial is running

St Louis, Missouri

• Clayton Sleep Institute — St Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Joseph Ojile, FCCP, D-ABSM — Clayton Sleep Institute
• Study coordinator: Matthew Uhles

Conditions Mild Obstructive Sleep Apnea; mild OSA; positional therapy; supine avoidance; lateral sleeping