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
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
Treatments tested in this trial
- MedCline Sleep System
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov