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Obstructive Sleep ApneaNCT05445869

Severe OSA Study (SOS)

A study testing ProSomnus® EVO Sleep and Snore Device in people with Obstructive Sleep Apnea and Sleep Apnea, run by ProSomnus Sleep Technologies at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Obstructive Sleep Apnea, Sleep Apnea
What is being tested?
ProSomnus® EVO Sleep and Snore Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
5 sitesUnited States
Study dates
12 Sep 2022to 15 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

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, 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).
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Advanced ENT Physicians and Surgeons of CNY

    Fayetteville, New York, 13066

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mount Sinai Integrative Sleep Center

    New York, New York, 10010

  • Stanford Sleep Medicine Clinic

    Redwood City, California, 94063

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ProSomnus® EVO Sleep and Snore Device
Keywords
oral appliance, mandibular advancement device
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProSomnus® EVO Sleep and Snore DeviceDevice

    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.

Study groups in NCT05445869
Study groupRoleWhat they receive
EVO Sleep and Snore DeviceExperimentalParticipants will be provided with a custom EVO Sleep and Snore Device
Receives: Device: ProSomnus® EVO Sleep and Snore Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy (apnea-hypopnea index)

    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.

    Measured: 6 months

  2. Efficacy (oxygen desaturation index)

    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.

    Measured: 6 months

  3. Evaluation of safety (adverse events, dental examinations, safety examinations)

    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.

    Measured: 6 months

Secondary outcomes (1)

  1. Epworth Sleepiness Scale

    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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start12 Sep 2022
  3. Primary completion15 Feb 2024
  4. Study completion15 Feb 2024

Why it stopped: Study terminated by Sponsor.

Resources

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445869
Sponsor's protocol ID
PST202101
Status last verified
Apr 2024
First submitted
30 Jun 2022
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ProSomnus® EVO Sleep and Snore Device in people with Obstructive Sleep Apnea and Sleep Apnea, run by ProSomnus Sleep Technologies at 5 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 12 inclusion and 20 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: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study was stopped early (reason given: Study terminated by Sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (apnea-hypopnea index) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05445869.

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 18 Apr 2024.

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