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Severe OSA Study (SOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05445869
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
ProSomnus Sleep Technologies

Brief Summary:
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Sleep Apnea Device: ProSomnus® EVO Sleep and Snore Device Not Applicable

Detailed Description:
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea (OSA). Study participants will receive a custom ProSomnus EVO Sleep and Snore device and then be tested using a Type II home sleep apnea test (HSAT) to determine if they have achieved apnea-hypopnea index (AHI) < 15 h-1 with the device in place. Home sleep apnea testing will be conducted at predetermined timepoints rather than based on subjective measures such as symptom alleviation. After completing a set device advancement and testing protocol, study participants will complete a final HSAT six months after therapy initiation. This value will be used to determine the therapeutic success rate of the appliance. Safety evaluations will be conducted at each study visit that takes place after therapy initiation. These evaluations, along with dental examinations and adverse event reports, will be used to determine if the safety endpoint is met. Participants will continue to be followed for an additional six months after collection of data for the primary endpoints.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Single-Arm, Open-Label, Observational Study on the Safety and Effectiveness of the ProSomnus EVO Sleep and Snore Device in the Treatment of Severe Obstructive Sleep Apnea
Actual Study Start Date : September 12, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea Snoring

Arm Intervention/treatment
Experimental: EVO Sleep and Snore Device
Participants will be provided with a custom EVO Sleep and Snore Device
Device: ProSomnus® EVO Sleep and Snore Device
The ProSomnus® EVO Sleep and Snore Device is an intraoral device for snoring and obstructive sleep apnea. It works by repositioning the mandible during sleep, thereby improving the flow of air through the patient's pharyngeal space. The ProSomnus® EVO Sleep consists of maxillary and mandibular device arches that are CAD/CAM designed with twin-mated posts and digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.




Primary Outcome Measures :
  1. Efficacy (apnea-hypopnea index) [ Time Frame: 6 months ]
    The AHI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve an AHI < 15 h-1 with the EVO Sleep and Snore Device 6 months after initiation of the therapy.

  2. Efficacy (oxygen desaturation index) [ Time Frame: 6 months ]
    The ODI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve decrease in ODI from baseline of 25% or more with the EVO Sleep and Snore Device 6 months after initiation of the therapy.

  3. Evaluation of safety (adverse events, dental examinations, safety examinations) [ Time Frame: 6 months ]
    The primary safety endpoint is to demonstrate an acceptable safety profile of the EVO Sleep and Snore Device, determined through assessment of all reported adverse events, dental examinations, and safety evaluations. There will be no formal statistical analysis.


Secondary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: 6 months ]
    The secondary endpoint is to demonstrate that the minimum clinically important difference (MCID) of -2 on the Epworth Sleepiness Scale (ESS) is achieved in participants with moderate to excessive daytime sleepiness (defined as ESS > 12). The Epworth Sleepiness Scale is a scale that ranges from 0 (no daytime sleepiness) to 18 (excessive daytime sleepiness).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, of any race, aged 18-80 years (inclusive)
  4. Diagnosed with uncomplicated severe OSA (i.e., AHI > 30 h-1); where uncomplicated is defined by the absence of:

    1. Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
    2. Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia).
    3. Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
  5. Body mass index (BMI) < 40 kg/m2
  6. Neck circumference < 50 cm
  7. Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 > 87%
  8. Mandibular range of motion > 5 mm in protrusive direction
  9. Adequate dentition, as determined by the site dentist

Exclusion Criteria:

  1. Inability to breathe through the nose comfortably
  2. Presence of > 25% CSA
  3. Presence of positional obstructive sleep apnea per Cartwright's definition32
  4. History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension. History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy, is permitted
  5. Presence of hypoglossal nerve stimulation device
  6. Use of CPAP or OAT within the two weeks prior to the screening HSAT
  7. History of OAT that has been demonstrated to provide effective therapy within the two years prior to the screening HSAT
  8. Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
  9. Loose teeth or advanced periodontal disease
  10. History of temporomandibular joint disorder
  11. Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
  12. Presence of congestive heart failure, recurrent atrial fibrillation, or coronary artery disease
  13. Presence of neuromuscular diseases, hypoventilation disorders, or cerebrovascular disease
  14. Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension
  15. History of cerebrovascular incident within the last 12 months
  16. Use of pacemaker or other life supporting device
  17. Anticipated change in body weight > 5% during the study period
  18. Participation in other studies that could interfere with the study protocol
  19. Pregnancy or lactation
  20. In the opinion of the investigator, unsuitable for inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05445869


Contacts
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Contact: Director, Medical Affairs 844 537 5337 info@prosomnus.com

Locations
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United States, California
Stanford Sleep Medicine Clinic Recruiting
Redwood City, California, United States, 94063
Contact: Neehar Thumaty       neehart@standford.edu   
Principal Investigator: Clete Kushida, MD, PhD         
Sub-Investigator: Audrey Yoon, DDS         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nicole Calianese    617-732-8977    ncalianese@partners.org   
Principal Investigator: Ludovico Messineo, MD, PhD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Bri Schimelpfenig    612-626-8689    schim225@umn.edu   
Principal Investigator: Bimaje Akpa, MBBS         
Sub-Investigator: Jon Parker, DDS         
United States, New York
Advanced ENT Physicians and Surgeons of CNY Active, not recruiting
Fayetteville, New York, United States, 13066
Mount Sinai Integrative Sleep Center Recruiting
New York, New York, United States, 10010
Contact: Kaveh Gaynor-Sodeifi    917-471-1682    kaveh.gaynor-sodeifi@mssm.edu   
Principal Investigator: David Rapoport, MD         
Sub-Investigator: David Binder, DDS         
Sub-Investigator: Thomas Tolbert, MD         
Sponsors and Collaborators
ProSomnus Sleep Technologies
Investigators
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Study Director: Erin Mosca, PhD ProSomnus Sleep Technologies
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Responsible Party: ProSomnus Sleep Technologies
ClinicalTrials.gov Identifier: NCT05445869    
Other Study ID Numbers: PST202101
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by ProSomnus Sleep Technologies:
oral appliance
mandibular advancement device
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases