Summary

Prosomnus makes severeral oral appliances for the treatment of snoring and sleep apnea using computer aided design/ computer aided manufacturing for individually customized device creation. The various claims regarding improvement in device comfort and durability compared to alternative oral appliance therapy options typically cite “ProSomnus Institutional Review Board Study data on file,” with limited peer-reviewed literature available for comparison of specific model performance. FDA indications cite the ProSomnus [CA], EVO, and EVO [PH] Sleep and Snore Devices for the indication of reducing snoring and mild to moderate OSA in adults. The [CA], EVO, and EVO [PH] devices have FDA clearance with and without the optional Patient Monitoring provided by an embedded DentiTrac (Braebon Inc.). See the DentiTrac review for more information about the compliance tracking device.

Claimed Capabilities/Measurements

ProSomnus makes several oral appliance therapies for the treatment of snoring and mild to moderate obstructive sleep apnea (OSA). The EVO Sleep and Snore device is the baseline device for OSA, consisting of independent upper and lower arches which interface for mandibular advance. The EVO Select Sleep and Snore device claims improved performance and comfort over the EVO due to a smaller device profile and proprietary material called MG6 ™. The EVO Guided Sleep and Snore device is similar, but uniquely claims to reposition the hyo-glossal complex to encourage anterior tongue posture and mouth closure. The baseline EVO, Select, and Guided deviecs require replacement of the arches when adjustments are needed. Alternatively, the EVO [PH] Sleep and Snore Device has a different mechanism, a Herbst-style using dual arms for adjustable advancement, while the [CA] variant allows for continuous advancement. Several other default and customization options are available. Prosomnus offers the capability for a DentiTrac micro-recorder (Braebon Inc.) to be embedded to measure compliance.

Mechanisms

When the DentiTrac micro-recorded is embedded, the time the device is worn is measured using a proprietary algorithm.

Sensors

The sensors used in the DentiTrac System are not publically reported.

Technical Considerations

The DentiTrac system is designed to store data for download every 6 months. Download occurs using the infrared communication between the micro-recorder and DentiTrac base station. Clinicians can review compliance data using the cloud interface.

Publications

Citation: Sall E, Smith K, Desai A, Carollo JA, Murphy MT, Kim S, Liptak LA. Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly From a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea. Cureus. 2023 Dec 7;15(12):e50107. doi: 10.7759/cureus.50107. PMID: 38077673; PMCID: PMC10703343.

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Study Summary: This study evaluated the clinical performance of a novel, precision, oral appliance therapy (OAT) medical device made entirely from a US Pharmacopeia (USP) medical grade class VI qualified material for the treatment of obstructive sleep apnea (OSA). This was a multi-center, single-arm, chart-based, retrospective study of 91 patients diagnosed with OSA, treated utilizing a novel, precision, OAT medical device. Eighty-nine percent of all subjects diagnosed with all levels of OSA severity were successfully treated to an apnea hypopnea index (“AHI”) < 10 events per hour. Ninety-eight percent of subjects diagnosed with mild to moderate OSA were successfully treated to an AHI < 10. Eighty percent of subjects with severe OSA, without screening or excluding subjects for airway collapse profile, were successfully treated to an AHI < 20 with a 50% improvement in AHI.

Citation: Stern J, Lee K, Kuhns D, Martinez-Kratz JF. Efficacy and Effectiveness of the ProSomnus® [IA] Sleep Device for the Treatment of Obstructive Sleep Apnea: EFFECTS Study. Cureus. 2021 Jun 2;13(6):e15391. doi: 10.7759/cureus.15391. PMID: 34249542; PMCID: PMC8252976

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Study Summary: This study evaluated the effectiveness of a new mandibular advancement device (MAD) (Prosomnus® [IA] Sleep Device, Prosomnus Sleep Technologies, Pleasanton CA) fitted with a compliance tracker as a first-line treatment in a population of patients with mild to severe obstructive sleep apnea (OSA). Treatment effectiveness was measured using pre and post-treatment home sleep testing (HST) and validated sleep and quality of life questionnaires. Mean disease alleviation (MDA) was calculated to compare the treatment effectiveness of MAD to historical continuous positive airway pressure (CPAP) effectiveness data. MAD was found to be an effective first-line treatment for patients with mild, moderate, and severe sleep apnea with excellent compliance rates, similar to or better than CPAP, and an equal or better MDA of 56.7% compared to literature values of 50% for CPAP.

Clinical Trials

Related Technologies

The following reviews should be published soon: Slow Wave DS8, Hushd Pro Avera, Silent Nite 3D, Prosomnus EVO, SomnoGuard (AP Pro, SPX, AP 2, 3), EMA 3D, DentiTrac, Rest Assure