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

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

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

OSA is a common sleep disorder characterized by partial or complete obstruction of the upper airway during sleep that leads to intermittent pauses in breathing (apneas) or shallow breathing (hypopneas).

These interruptions can cause fragmented sleep, leading to daytime fatigue, cognitive impairments, and other health issues. Addressing mild OSA early is important, as it can progress to more severe forms if left untreated. OSA severity is measured using the Apnea-Hypopnea Index (AHI), which counts the number of apneas and hypopneas per hour of sleep. Estimates suggest that mild OSA, defined by an AHI of 5-14.9 events per hour, affects about 9-38% of adults with and increased prevalence in men and older adults. The Oxygen Desaturation Index (ODI) has been shown to be an alternative measure for OSA severity since AHI and ODI are heavily correlated and ODI is a valid predictor of OSA severity.

There are many treatment options available for patients with various severities of OSA. The gold standard for treating moderate or severe sleep apnea is Continuous Positive Airway Pressure (CPAP). CPAP therapy involves wearing a mask that provides a continuous flow of air to keep the airway open during sleep. However, some patients find CPAP uncomfortable or inconvenient, leading to patient compliance issues. Another option for patients with moderate or severe OSA is the use of intraoral devices. These devices reposition the lower jaw and tongue to keep the airway open. They require custom fitting by a dentist trained in sleep medicine. Access to these specialists, as well as concerns about discomfort and impact on teeth, can also limit their use as well as patient compliance.

For patients with mild OSA, positional therapy is a promising alternative. Positional therapy aims to prevent patients from sleeping in positions that exacerbate OSA, such as lying on their back (supine position), which has been demonstrated to worsen airway obstruction. Effective positional therapy should encourage side sleeping (lateral positioning) or elevating the head and shoulders, which can help reduce apneic events.

The American Academy of Sleep Medicine (AASM) "Practice Parameters for Medical Therapy of OSA" recommends positional therapy as an effective, non-invasive secondary treatment for mild OSA, especially when used alongside primary treatments like CPAP (AASM Guideline 3.5). FDA-authorized devices used for positional therapy include specialized pillows, belts, and electronic trainers that help maintain a side-sleeping or elevated position throughout the night. These devices are attractive solutions for patients for which CPAP may not be a practical first-line solution, such as patients with mild OSA.

The device that is the subject of this submission, the MedCline Sleep System, is a pillow-based positional therapy device based on the sleep positioning principles described above.

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)