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

NCT07492420 | Recruiting FDA Device

• 1 other identifier: MSS001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

mild OSA; positional therapy; supine avoidance; lateral sleeping

Outcome Measures

Primary Outcomes (2)

• Reduction of AHI on Apnea-Hypopnea Index scale

  Change in apneas per hour as measured by PSG (in-lab)

  Night 1 to Night 8

• Reduction of ODI on Oxygen Desaturation Index Scale

  Change in oxygen desaturation per hour via PSG (in-lab)

  Night 1 to Night 8

Secondary Outcomes (1)

• Reduction in Snoring

  Night 1 to Night 8

Study Arms (1)

Intervention Device

EXPERIMENTAL

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

Device: MedCline Sleep System

Interventions

MedCline Sleep System DEVICE

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

Intervention Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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)

Sponsors & Collaborators

• Amenity Health, Inc.: lead

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

RECRUITING

Related Publications (4)

• Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T; American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep. 2006 Nov;29(11):1415-9.

  PMID: 17162987 BACKGROUND

• van der Hoek LH,Rosenmöller BRAM,van de Rijt LJM,de Vries R,Aarab G,Lobbezoo F

  BACKGROUND

• Varghese L, Rebekah G, N P, Oliver A, Kurien R. Oxygen desaturation index as alternative parameter in screening patients with severe obstructive sleep apnea. Sleep Sci. 2022 Jan-Mar;15(Spec 1):224-228. doi: 10.5935/1984-0063.20200119.

  PMID: 35273770 BACKGROUND

• Peppard PE,Young T,Barnet JH,Palta M,Hagen EW,Hla KM

  BACKGROUND

Study Officials

• Joseph Ojile, FCCP, D-ABSM

  Clayton Sleep Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Uhles

CONTACT

314-645-5855; UhlesM@claytonsleep.com

Nicholas Bossaller

CONTACT

Ph: (314) 353-9017; BossallerN@claytonsleep.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, prospective, single-arm, within-subject study to evaluate the safety and effectiveness of the MedCline Sleep System.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)