- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445869
Severe OSA Study (SOS)
April 16, 2024 updated by: ProSomnus Sleep Technologies
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Director, Medical Affairs
- Phone Number: 844 537 5337
- Email: info@prosomnus.com
Study Locations
-
-
California
-
Redwood City, California, United States, 94063
- Stanford Sleep Medicine Clinic
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
New York
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Fayetteville, New York, United States, 13066
- Advanced ENT Physicians and Surgeons of CNY
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New York, New York, United States, 10010
- Mount Sinai Integrative Sleep Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, of any race, aged 18-80 years (inclusive)
Diagnosed with uncomplicated severe OSA (i.e., AHI > 30 h-1); where uncomplicated is defined by the absence of:
- 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.
- 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).
- Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
- Body mass index (BMI) < 40 kg/m2
- Neck circumference < 50 cm
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 > 87%
- Mandibular range of motion > 5 mm in protrusive direction
- Adequate dentition, as determined by the site dentist
Exclusion Criteria:
- Inability to breathe through the nose comfortably
- Presence of > 25% CSA
- Presence of positional obstructive sleep apnea per Cartwright's definition32
- 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
- Presence of hypoglossal nerve stimulation device
- Use of CPAP or OAT within the two weeks prior to the screening HSAT
- History of OAT that has been demonstrated to provide effective therapy within the two years prior to the screening HSAT
- Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
- Loose teeth or advanced periodontal disease
- History of temporomandibular joint disorder
- Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
- Presence of congestive heart failure, recurrent atrial fibrillation, or coronary artery disease
- Presence of neuromuscular diseases, hypoventilation disorders, or cerebrovascular disease
- 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
- History of cerebrovascular incident within the last 12 months
- Use of pacemaker or other life supporting device
- Anticipated change in body weight > 5% during the study period
- Participation in other studies that could interfere with the study protocol
- Pregnancy or lactation
- In the opinion of the investigator, unsuitable for inclusion in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EVO Sleep and Snore Device
Participants will be provided with a custom 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months
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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.
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6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Erin Mosca, PhD, ProSomnus Sleep Technologies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2022
Primary Completion (Actual)
February 15, 2024
Study Completion (Actual)
February 15, 2024
Study Registration Dates
First Submitted
June 30, 2022
First Submitted That Met QC Criteria
June 30, 2022
First Posted (Actual)
July 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PST202101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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