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Oral Appliance
ProSomnus® EVO Device for Obstructive Sleep Apnea
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new sleep apnea device to see if it's safe and effective.
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.Check my eligibility
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.See study design
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 belowSelect...
My neck circumference is less than 50 cm.
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I can move my lower jaw forward more than 5 mm.
Select...
I have a serious sleep disorder that affects my sleep quality.
Select...
I have severe sleep apnea without other serious health issues.
Select...
I have severe sleep apnea without other major health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy (apnea-hypopnea index)
Efficacy (oxygen desaturation index)
Evaluation of safety (adverse events, dental examinations, safety examinations)
Secondary outcome measures
Epworth Sleepiness Scale
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
Find a Location
Who is running the clinical trial?
ProSomnus Sleep TechnologiesLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Erin Mosca, PhDStudy DirectorProSomnus Sleep Technologies
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My neck circumference is less than 50 cm.My dentist says my teeth are in good condition.I can move my lower jaw forward more than 5 mm.You have a device that stimulates the hypoglossal nerve.I've had surgery to correct sleep apnea, like UPPP, MMA, or tongue suspension.You have certain medical conditions or situations, such as severe dental problems, heart or lung issues, recent stroke, certain medical devices, or pregnancy, that make you unsuitable for the study.You have conditions that could make it hard to collect and understand data from a home sleep apnea test.Your body mass index (BMI) is less than 45 kg/m2.I have used a CPAP machine or oral appliance therapy in the last two weeks.I have a serious sleep disorder that affects my sleep quality.I have severe sleep apnea without other serious health issues.I have had effective oral appliance therapy in the last 2 years.You have more than 25% of a certain type of cells in your body.I expect changes in my treatment that might affect my sleep apnea severity.I have sleep apnea that worsens in certain positions.I cannot breathe through my nose easily.You do not have severe drops in your blood oxygen levels while sleeping, which is shown by having an average nighttime oxygen level of more than 87%.I am between 18 and 80 years old.I have severe sleep apnea without other major health issues.I have severe sleep apnea without complications.I have a condition that could cause sleep breathing problems, like heart disease or muscle weakness.Your body mass index (BMI) is less than 40.
Research Study Groups:
This trial has the following groups:- Group 1: EVO Sleep and Snore Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05445869 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available for participants in this trial?
"It appears that this clinical trial is still actively looking for participants, as the information posted on clinicaltrials.gov was last updated yesterday (9/13/2022). This study was first made public on 9/12/2022."
Answered by AI
Is it permissible to enroll minors in this research experiment?
"This clinical trial is seeking participants aged 18 to 80. Those under the age of 18 can participate in 48 other studies, while those above 65 have access to 238 trials."
Answered by AI
Am I eligible to enroll in this research endeavor?
"This medical trial is searching for a cohort of 100 individuals, aged 18-80. To be eligible to participate, patients must have an oxygenation saturation during sleep higher than 87%, provide written informed consent and be willing to comply with the study procedures throughout its duration. Additionally, potential participants ought not suffer from any cardiopulmonary diseases or neuromuscular conditions that could cause respiratory muscle weakness; they must also show no signs of central hypersomnolence disorders, parasomnia nor severe insomnia and boast a body mass index lower than 45 kg/m2 as well as mandibular range of motion surpassing 5 mm in protr"
Answered by AI
What is the total participant count for this clinical exploration?
"Affirmative, the clinicaltrials.gov page indicates that enrolment for this medical trial is ongoing. The study was initially posted on September 12th 2022 and recently updated on September 13th 2022. Up to one hundred patients are wanted from a single site of recruitment."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
Connecticut
What site did they apply to?
Advanced ENT Physicians and Surgeons of CNY
Mount Sinai Integrative Sleep Center
University of Minnesota
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I prefer to treat my sleep apnea without medications so this trial seems like an ideal option.
PatientReceived 2+ prior treatments
I was diagnosed with obstructive sleep apnea, but after I lost a lot of weight, it seemed to mostly go away. But my wife said it's come back with a vengeance.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Mount Sinai Integrative Sleep Center: < 48 hours
Average response time
- < 2 Days
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