Obstructive Sleep ApneaSLEEPNCT07090395
Severe Label Expansion for EVO Products Trial
A study testing EVO Sleep and Snore Device in people with Obstructive Sleep Apnea, run by ProSomnus Sleep Technologies at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- EVO Sleep and Snore Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 obstructive, interstitial lung disease, or pulmonary hypertension]). Examples of such conditions include significant cardiopulmonary disease (congestive heart failure, recurrent atrial fibrillation, coronary artery disease, resistant hypertension), potential respiratory muscle 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Star Sleep and Wellness
Dallas, Texas, 75251
Xzavier Ozuna, MBA, xozuna@stswell.com
Kent Smith, DDS
- Recruiting
Mount Sinai Integrative Sleep Center
New York, New York, 10010
Research Manager, 646-988-6927, srisaranya.ravi@mssm.edu
David Rapoport, MD
About this study
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.
Read more
Endpoints: The primary effectiveness endpoint is the Sher criteria defined as a reduction of Apnea-Hypopnea Index (AHI) of at least 50% from the baseline value and a post-treatment AHI of less than 20 events/hour at 6 months following initiation of Oral Appliance Therapy (OAT) titration. AHI will be collected using HSAT at baseline and 6 months. The primary safety objective is to evaluate safety by summarizing all reported device and/or procedure related adverse events from the time the EVO device is introduced through 6 months. Study Population: A maximum of 49 individuals over the age of 18 years with severe obstructive sleep apnea will be enrolled.
Description of Sites/Facilities Enrolling Participants: The study will be conducted at up to four sites, up to two of which could be located outside of the US. Description of Study Device: The study device is the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). The device is a mandibular repositioning device used to treat obstructive sleep apnea. The device is currently cleared for the treatment of mild and moderate OSA.
Study Duration: The time from when the study opens to enrollment until completion of data analyses is estimated to be 15 months.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- EVO Sleep and Snore Device
- Keywords
- oral appliance therapy, mandibular advancement device, ProSomnus
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO Sleep and Snore DeviceDevice
ProSomnus EVO Sleep and Snore Device mandibular advancement device
| Study group | Role | What they receive |
|---|---|---|
| EVO Sleep and Snore Device | Experimental | Not described Receives: Device: EVO Sleep and Snore Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sher responder rate endpoint
Proportion of participants who meet the Sher criteria at outcome, defined as a reduction of apnea-hypopnea index less than 20 events/hour and 50% or greater reduction from the baseline value.
Measured: 6 months
Incidence of adverse events
Evaluation of safety by summarizing all reported device- and/or procedure-related adverse events from the time the EVO device is introduced through 6 months.
Measured: 6 months
Secondary outcomes (7)
Sleep apnea-specific hypoxic burden
Proportion of participants achieving a sleep apnea-specific hypoxic burden less than 60 %min/h at 6 months
Measured: 6 months
Epworth Sleepiness Scale change from baseline
Change in Epworth Sleepiness Scale from baseline to 6 months. The Epworth Sleepiness Scale ranges from 0 to 24, with 0 being the lowest and 24 being the highest score indicating propensity for sleep.
Measured: 6 months
Sher criteria responder rate point estimate
Responder rate point estimate for the Sher criteria post-titration and at 6 months
Measured: 6 months
Severity classification change
OSA severity classification change from baseline to post-titration and 6 months
Measured: 6 months
Apnea-hypopnea index change from baseline
Change in AHI, ODI and SASHB change from baseline to 6 months
Measured: 6 months
Oxygen desaturation index change from baseline
Change in oxygen desaturation index from baseline to 6 months
Measured: 6 months
Sleep apnea-specific hypoxic burden change from baseline
Change in sleep apnea-specific hypoxic burden from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Aug 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProSomnus Sleep Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Mosca, PhD, Study director, ProSomnus Sleep Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090395
- Sponsor's protocol ID
- SP-005
- Acronym
- SLEEP
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Label Expansion for EVO Products Trial
- ClinicalTrials.gov ID
- NCT07090395
- Acronym / sponsor ID
- SLEEP / SP-005
- Conditions
- Obstructive Sleep Apnea
- Keywords
- oral appliance therapy, mandibular advancement device, ProSomnus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- ProSomnus Sleep TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Endpoints: The primary effectiveness endpoint is the Sher criteria defined as a reduction of Apnea-Hypopnea Index (AHI) of at least 50% from the baseline value and a post-treatment AHI of less than 20 events/hour at 6 months following initiation of Oral Appliance Therapy (OAT) titration. AHI will be collected using HSAT at baseline and 6 months. The primary safety objective is to evaluate safety by summarizing all reported device and/or procedure related adverse events from the time the EVO device is introduced through 6 months. Study Population: A maximum of 49 individuals over the age of 18 years with severe obstructive sleep apnea will be enrolled.
Description of Sites/Facilities Enrolling Participants: The study will be conducted at up to four sites, up to two of which could be located outside of the US. Description of Study Device: The study device is the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA). The device is a mandibular repositioning device used to treat obstructive sleep apnea. The device is currently cleared for the treatment of mild and moderate OSA.
Study Duration: The time from when the study opens to enrollment until completion of data analyses is estimated to be 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVO Sleep and Snore Device | Experimental | Device: EVO Sleep and Snore Device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Body mass index (BMI) < 35 kg/m2
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVO Sleep and Snore DeviceProSomnus EVO Sleep and Snore Device mandibular advancement device | Device | EVO Sleep and Snore Device |
Primary outcome
Sher responder rate endpoint
Time frame: 6 months
Proportion of participants who meet the Sher criteria at outcome, defined as a reduction of apnea-hypopnea index less than 20 events/hour and 50% or greater reduction from the baseline value.
Incidence of adverse events
Time frame: 6 months
Evaluation of safety by summarizing all reported device- and/or procedure-related adverse events from the time the EVO device is introduced through 6 months.
7 secondary outcomes
Sleep apnea-specific hypoxic burden
Time frame: 6 months
Epworth Sleepiness Scale change from baseline
Time frame: 6 months
Sher criteria responder rate point estimate
Time frame: 6 months
Severity classification change
Time frame: 6 months
Apnea-hypopnea index change from baseline
Time frame: 6 months
Oxygen desaturation index change from baseline
Time frame: 6 months
Sleep apnea-specific hypoxic burden change from baseline
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Mosca, PhD study director
ProSomnus Sleep Technologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVO Sleep and Snore Device in people with Obstructive Sleep Apnea, run by ProSomnus Sleep Technologies at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Mosca, PhD (925-803-8643, emosca@prosomnus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sher responder rate endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.