Obstructive Sleep ApneaCO-STARNCT05608486
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
A study testing aerSleep II in people with Obstructive Sleep Apnea and Sleep Apnea, run by Sommetrics, Inc..
Trial summary
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea
- What is being tested?
- aerSleep II
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- The subject completed study SOM-029 (SUPRA).
- The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.
- In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.
Who cannot join
- The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.
- Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.
- The subject is pregnant or plans to become pregnant during the course of the study.
Trial locations and contacts
No sites are listed yet.
Richard Rose, M.D. contact
About this study
Official title: Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial (CO-STAR)
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
Read the detailed description
This is a multi-center uncontrolled continuation study designed to mimic real-world use of the aerSleep II System for subjects that have completed the SOM-029 protocol.
Subjects will use the aerSleep II nightly at a fixed pressure of -30 cmH2O. Internal electronics will record various measures of how the device is being used and how it performs.
Subjects will have a video visit with the study site approximately every 30 days, and, if the Investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. During these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. The Investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (OSA).
Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Being tested
- aerSleep II
- 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.
aerSleep IIDevice
Also called Continuous Negative External Pressure (cNEP)
The aerSleep® II System includes a soft silicone collar, which is placed on the anterior neck. Integrated with the collar is a vacuum pump module (VPM), which cordlessly powers the generation of negative pressure within the collar's cavity. This negative pressure pulls the underlying tissues forward, maintaining airway patency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kingman P. Strohl, M.D., Principal investigator, Case Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608486
- Sponsor's protocol ID
- SOM-030
- Acronym
- CO-STAR
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial (CO-STAR)
- ClinicalTrials.gov ID
- NCT05608486
- Acronym / sponsor ID
- CO-STAR / SOM-030
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- First posted
- 8 Nov 2022 (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.
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
Detailed description
This is a multi-center uncontrolled continuation study designed to mimic real-world use of the aerSleep II System for subjects that have completed the SOM-029 protocol.
Subjects will use the aerSleep II nightly at a fixed pressure of -30 cmH2O. Internal electronics will record various measures of how the device is being used and how it performs.
Subjects will have a video visit with the study site approximately every 30 days, and, if the Investigator feels it is warranted or at the subject's discretion, an in-person visit at the study site will occur approximately every 90 days. During these visits, subjects will be queried for adverse events and asked to complete simple subjective evaluations of their experiences. The Investigator will complete a scale rating how well the device is managing the subject's obstructive sleep apnea (OSA).
Data collected from the device will be retrieved approximately every 90 days to monitor vacuum delivery and subject compliance.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject completed study SOM-029 (SUPRA).
- The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.
- In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.
Key exclusion criteria (3 listed)
- The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.
- Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.
- The subject is pregnant or plans to become pregnant during the course of the study.
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 |
|---|---|---|
| aerSleep IIAlso: Continuous Negative External Pressure (cNEP)The aerSleep® II System includes a soft silicone collar, which is placed on the anterior neck. Integrated with the collar is a vacuum pump module (VPM), which cordlessly powers the generation of negative pressure within the collar's cavity. This negative pressure pulls the underlying tissues forward, maintaining airway patency. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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. This study is not recruiting at the moment.
Richard Rose, M.D. contact
Kingman P. Strohl, M.D. principal investigator
Case Western Reserve University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing aerSleep II in people with Obstructive Sleep Apnea and Sleep Apnea, run by Sommetrics, Inc..
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Koehler (760-295-5620, ekoehler@sommetrics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 16 Apr 2024; AzTrials last refreshed its copy on 27 Oct 2026.