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New treatment option for Obstructive Sleep Apnea
Official title Severe Label Expansion for EVO Products Trial
ClinicalTrials.gov ID: NCT07090395
What this study is testing
- What it's testing
- Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). Objectives: To determine the safety and effectiveness of the EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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, aged 18-80 years (inclusive)
- Diagnosed with uncomplicated severe OSA (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...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to breathe through the nose comfortably
- Presence of \> 25% CSA
- Presence of positional OSA per Amsterdam Positional OSA Classification I definition
- History of surgery intended to alter anatomy for the correction of OSA
- E.g., uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), tongue/hyoid suspension, slow maxillary expansion
See the full eligibility 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, aged 18-80 years (inclusive)
- Diagnosed with uncomplicated severe OSA (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 [e.g., resulting from severe chronic...
- 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...
- Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
- Body mass index (BMI) \< 35 kg/m2
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 \> 87%
- Adequate mandibular range of motion
- Adequate dentition
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to breathe through the nose comfortably
- Presence of \> 25% CSA
- Presence of positional OSA per Amsterdam Positional OSA Classification I definition
- History of surgery intended to alter anatomy for the correction of OSA
- E.g., uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), tongue/hyoid suspension, slow maxillary expansion
- History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy, is permitted.
- Presence of hypoglossal nerve stimulation device (active or inactive)
- Use of CPAP or OAT within the two weeks prior to the baseline sleep study
- History of OAT that has been confirmed to provide effective therapy within the two years prior to the baseline sleep study
- Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgery, weight loss drug, UPPP, MMA, tongue/hyoid suspension, etc.)
- 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
- Use of pacemaker or other life-supporting device
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.