35 Participants NeededMy employer runs this trial

MedCline Sleep System for Sleep Apnea

MU
NB
Overseen ByNicholas Bossaller
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the MedCline Sleep System, a specialized sleep positioning device, can safely and effectively reduce symptoms of mild obstructive sleep apnea (OSA), a condition where breathing briefly stops during sleep. Participants will be compared using their own pillow versus the MedCline Sleep System to determine which provides more relief. Individuals with mild OSA, who sleep on a regular mattress, and are generally healthy may be suitable candidates.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep quality for many.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been stable on any medications for at least 3 months before joining. If you're using substances or medications that significantly alter sleep or breathing, you may not be eligible.

What prior data suggests that the MedCline Sleep System is safe for reducing symptoms related to mild OSA?

Research has shown that most people find the MedCline Sleep System easy to use. Already approved for purposes such as easing acid reflux and shoulder pain, it is likely safe for most users. Many users report better sleep and symptom relief when using it. No major reports of adverse side effects or harmful reactions have emerged. Overall, the MedCline Sleep System appears to be a safe choice for improving sleep quality.12345

Why are researchers excited about this trial?

The MedCline Sleep System is unique because it targets mild obstructive sleep apnea (OSA) through positional therapy, a different approach compared to traditional treatments like CPAP machines or oral appliances. Unlike these standard options that often involve wearing a mask or a mouthpiece, the MedCline system is designed to naturally encourage sleeping in a position that prevents airway collapse by using a specially designed pillow system. Researchers are excited about this treatment because it offers a non-invasive, comfortable, and potentially more user-friendly alternative for managing mild OSA, which could significantly improve adherence and overall patient outcomes.

What evidence suggests that the MedCline Sleep System is effective for reducing symptoms of mild OSA?

Research has shown that the MedCline Sleep System can help with sleep problems. Studies found that 93% of users experienced less heartburn at night, and 89% experienced less regurgitation. While these results focus on acid reflux, they also suggest that the system might improve overall sleep quality. Among those with shoulder pain, 95% reported better sleep. The system includes a specially shaped pillow that helps maintain a comfortable position, which might also reduce mild sleep apnea symptoms. This trial will compare outcome measures for participants using their own pillows versus the MedCline Sleep System, supporting its potential to enhance comfort and possibly ease mild sleep apnea symptoms.678910

Who Is on the Research Team?

JO

Joseph Ojile, FCCP, D-ABSM

Principal Investigator

Clayton Sleep Institute

Are You a Good Fit for This Trial?

This trial is for adults with mild obstructive sleep apnea (OSA) who are in good overall health, routinely sleep on a standard mattress, and can use the MedCline Sleep System. People with moderate to severe OSA, certain medical conditions, recent sleep apnea surgery, or chronic pain that affects sleeping position cannot join.

Inclusion Criteria

I am 18 years old or older.
Ability to provide written informed consent in accordance with IRB principles
PSG or HST performed within last 24 months
See 4 more

Exclusion Criteria

Pregnant or planning to become pregnant during study period
I have had surgery for sleep apnea in the past six months.
I have been diagnosed with moderate to severe sleep apnea.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the MedCline Sleep System for positional therapy to reduce symptoms of mild OSA

1 week
Night 1 to Night 8 (in-lab)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MedCline Sleep System

Trial Overview

The study is testing the MedCline Sleep System—a special pillow designed to help people with mild OSA by encouraging side-sleeping—to see if it safely reduces symptoms of sleep apnea.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intervention DeviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amenity Health, Inc.

Lead Sponsor

Trials
3
Recruited
120+

Citations

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