Recruiting

MedCline Sleep System

Sponsor:

Amenity Health, Inc.

Code:

NCT07492420

Conditions

Mild Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MedCline Sleep System

Study Details

Brief 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.

Conditions

Mild Obstructive Sleep Apnea

Study ID

NCT07492420

Start date

Mar 1, 2026

Status verified date

Mar, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Device

This study will compare outcome measures for participants using their own pillow(s) vs. using the MedCline Sleep System.

Interventions

MedCline Sleep System

The MedCline Sleep System is an at-home positional therapy device to be placed on a bed surface.

Primary outcome measure

  • Reduction of AHI on Apnea-Hypopnea Index scale [ Time Frame: Night 1 to Night 8 ]
  • Reduction of ODI on Oxygen Desaturation Index Scale [ Time Frame: Night 1 to Night 8 ]

Central Contacts and Locations

Locations

Clayton Sleep Institute

Recruiting

St Louis, Missouri, United States, 63123

Contacts

Principal Investigator:

Joseph Ojile, FCCP, D-ABSM

More Information

Sponsor

Amenity Health, Inc.

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • mild OSA
  • positional therapy
  • supine avoidance
  • lateral sleeping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amenity Health, Inc. on 2026-03-27.