Health TrialsbyHealthPanel

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

ConditionMild Obstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmenity Health, Inc.

About this trial

The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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")

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • MedCline Sleep System

    Device

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

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Intervention DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reduction of AHI on Apnea-Hypopnea Index scale

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

Time frame
Night 1 to Night 8
2

Reduction of ODI on Oxygen Desaturation Index Scale

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

Time frame
Night 1 to Night 8

Secondary outcomes

1

Reduction in Snoring

Change in snoring during night

Time frame
Night 1 to Night 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amenity Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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