Four independent scientific abstracts accepted for the meeting contain data utilizing ProSomnus oral appliances.

Summary: ProSomnus Inc announced that four independent scientific abstracts utilizing their precision oral appliances for obstructive sleep apnea (OSA) have been accepted for the 2024 AADSM Annual Meeting. One abstract won the Clinical Excellence Award, and another featured over 1,200 patients. The studies demonstrate the effectiveness, safety, and high adherence of ProSomnus devices compared to CPAP therapy. BlueSleep’s virtual workflow with ProSomnus devices showed significant improvement in patient outcomes and increased accessibility for OSA treatment.

Key Takeaways: 

  • ProSomnus oral appliances are featured in four scientific abstracts at the 2024 AADSM Annual Meeting, with one study winning the prestigious Clinical Excellence Award.
  • Studies demonstrate that ProSomnus devices are highly effective, safe, and have high patient adherence rates, serving as a viable alternative to CPAP therapy for treating obstructive sleep apnea.
  • BlueSleep’s virtual workflow using ProSomnus devices significantly improved patient outcomes and accessibility, showing the feasibility of remote OSA treatment.

ProSomnus Inc, maker of oral appliance therapy for obstructive sleep apnea (OSA), announced that four independent scientific abstracts accepted for the 2024 AADSM Annual Meeting contain scientific data utilizing ProSomnus precision devices.

Additionally, one abstract won the prestigious Clinical Excellence Award, and another featured over 1,200 patients.

“ProSomnus is proud that our precision devices have been included in high quality, scientific, research that buttresses the rationale for non-invasive, non-CPAP treatment options for patients with OSA,” commented Len Liptak, Chief Executive Officer for ProSomnus Sleep Technologies. “Research and clinical practice demonstrate that ProSomnus precision oral devices are highly effective, associated with high levels of adherence, have an excellent safety record, and are covered by most medical insurances and Medicare.”

The abstracts: 

  • Abstract #018 (winner of the 2024 AADSM Clinical Excellence Award): “Overall Clinical Effectiveness of Oral Appliance Therapy as a First-Line Treatment Option Compared with Continuous Positive Airway Pressure in Patients with Moderate to Severe Obstructive Sleep Apnea: The FLOSAT Study”
  • Abstract #021: “Incidence of Adverse Effects with Mandibular Advancement Device Therapy and Impact on Treatment Modality Choice in Patients Diagnosed with Severe Obstructive Sleep Apnea”
  • Abstract #022: “Efficacy of Oral Appliance Therapy for Obstructive Sleep Apnea in a Virtual Workflow. A Review of 1,242 Cases.”
  • Abstract #023: “Comparison of Telemedicine Versus In-Office Delivery of Mandibular Advancement Devices. A Review of 757 Cases.”

The Details

Data from the First Line OSA Treatment (FLOSAT) study, a comparative study evaluating the clinical effectiveness of mandibular advancement therapy (MAD), reported that custom-made, titratable MAD devices (ProSomnus EVO) have significantly higher patient preference and at least non-inferior overall clinical effectiveness to CPAP therapy.

Analysis of a subset of the FLOSAT study data found comparable rates of adverse effects and levels of mandibular protrusion in patients with moderate and severe OSA. The findings underscore the significance of exploring safe and effective alternatives to CPAP for severe OSA and debunking myths surrounding the efficacy of MAD in this patient population.

The data from the FLOSAT study indicate that OSA therapy with ProSomnus EVO devices is safe, effective, and better adhered to than CPAP.

BlueSleep Research

BlueSleep, a virtual diagnosis and sleep apnea treatment provider, is presenting results of two studies at the 2024 AADSM Annual Meeting. In the first study, the effectiveness of ProSomnus oral appliance therapy was evaluated in 1,245 patients with a mix of mild, moderate, and severe sleep apnea. 

Patients obtained same-day online appointments with BlueSleep and received a home sleep test by mail. Patients inserted their ProSomnus devices at home with virtual assistance from BlueSleep’s dentists. Effectiveness was evaluated with post treatment home sleep tests. There was an overall improvement of the AHI by more than 50% for all severity categories.

In a second study, BlueSleep compared the initial fitting of ProSomnus devices either in a virtual or in-person workflow. There were no significant differences in outcomes in the two patient groups, confirming that the virtual delivery of ProSomnus oral appliances is feasible and desirable to improve accessibility to treatment for sleep apnea.

“We have successfully treated over 1,800 patients with ProSomnus oral appliances using our digital care platform,” says Jordan Stern, MD, CEO, and founder of BlueSleep, in a release. “Results of these studies confirm that the BlueSleep virtual workflow using the most advanced oral appliance therapy from ProSomnus can help increase availability of treatment to the one billion globally suffering from obstructive sleep apnea, including those who cannot tolerate or have failed treatment with CPAP.”