What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy and oral appliances like the ProSomnus EVO Sleep and Snore Device. CPAP therapy is highly effective but often has side effects such as nasal congestion, dry mouth, skin irritation, and discomfort from the mask, which can lead to low adherence. Oral appliances, which maintain airway patency by repositioning the jaw, may cause side effects like jaw pain, teeth discomfort, excessive salivation, and temporomandibular joint (TMJ) issues. Both treatments require careful management to minimize side effects and improve patient adherence.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA) that maintain airway patency during sleep. One of the primary treatments includes Positive Airway Pressure (PAP) devices, such as CPAP (Continuous Positive Airway Pressure), which are widely used and have been shown to be effective. Additionally, oral appliances like mandibular advancement devices (MADs) have been approved and are effective in improving the Apnea Hypopnea Index (AHI) and symptoms in many patients. These devices work by repositioning the lower jaw to keep the airway open during sleep. The ProSomnus EVO Sleep and Snore Device is an example of such an oral appliance currently being studied for its safety and effectiveness in severe OSA.

What other types of research exist?

Promising novel alternatives to the ProSomnus EVO Sleep and Snore Device for OSA patients include: 1) Mandibular advancement devices, such as the Somnomed G2® OAm, which have shown significant improvement in Apnea Hypopnea Index and symptoms. 2) Tongue-stabilizing devices (TSDs), which have demonstrated efficacy in reducing snoring frequency. 3) Auto-CPAP (APAP) devices, which offer personalized pressure adjustments and have shown similar efficacy to traditional CPAP in improving sleep quality and reducing sleepiness. These alternatives provide effective options for maintaining airway patency during sleep.

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Oral Appliance

ProSomnus® EVO Device for Obstructive Sleep Apnea

Q: What is the mechanism of action of this treatment?

Common treatments for Obstructive Sleep Apnea (OSA) focus on maintaining airway patency during sleep. Continuous Positive Airway Pressure (CPAP) delivers a constant stream of air through a mask to keep the airway open. Oral appliances, such as mandibular advancement devices, reposition the lower jaw and tongue to prevent airway collapse. Upper airway surgeries remove or reposition tissues to widen the airway. These treatments are essential for OSA patients as they directly address the airway obstruction, improving sleep quality and reducing associated health risks.

N/A

Waitlist Available

Research Sponsored by ProSomnus Sleep Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neck circumference < 50 cm

Mandibular range of motion > 5 mm in protrusive direction

Must not have

History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension

Presence of positional obstructive sleep apnea per Cartwright's definition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a custom-made device that people with severe sleep apnea wear during sleep. The device helps keep their airway open to improve breathing and reduce snoring.

Who is the study for?

Adults aged 18-80 with severe obstructive sleep apnea (AHI > 30), BMI < 45 kg/m2, good dental health, and stable medical condition. Must be able to breathe through the nose and have a neck circumference < 50 cm. Excludes those with central sleep apnea risks, recent OSA surgery or effective therapy, and certain medical conditions.

What is being tested?

The trial is testing the ProSomnus EVO Sleep and Snore Device's safety and effectiveness in treating severe obstructive sleep apnea. It's an open-label study where all participants receive the device without being compared to a control group.

What are the potential side effects?

Potential side effects may include discomfort in the jaw due to device use, possible dental issues like tooth movement or changes in bite alignment, gum irritation, dry mouth or excessive salivation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neck circumference is less than 50 cm.

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I can move my lower jaw forward more than 5 mm.

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I have a serious sleep disorder that affects my sleep quality.

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I have severe sleep apnea without other serious health issues.

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I have severe sleep apnea without other major health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had surgery to correct sleep apnea, like UPPP, MMA, or tongue suspension.

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I have sleep apnea that worsens in certain positions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy (apnea-hypopnea index)

Efficacy (oxygen desaturation index)

Evaluation of safety (adverse events, dental examinations, safety examinations)

Secondary study objectives

Epworth Sleepiness Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EVO Sleep and Snore DeviceExperimental Treatment1 Intervention

Participants will be provided with a custom EVO Sleep and Snore Device

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) focus on maintaining airway patency during sleep. Continuous Positive Airway Pressure (CPAP) delivers a constant stream of air through a mask to keep the airway open. Oral appliances, such as mandibular advancement devices, reposition the lower jaw and tongue to prevent airway collapse. Upper airway surgeries remove or reposition tissues to widen the airway. These treatments are essential for OSA patients as they directly address the airway obstruction, improving sleep quality and reducing associated health risks.

Non-continuous positive airway pressure treatment options in obstructive sleep apnoea: A pathophysiological perspective.An evidence-based approach to the management of snoring in adults.Management of simple snoring, upper airway resistance syndrome, and moderate sleep apnea syndrome.