Obstructive Sleep ApneaNCT03108417
Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
A study testing continuous negative external pressure in people with Obstructive Sleep Apnea, run by Sommetrics, Inc. at 1 site in United States.
Trial summary
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- continuous negative external pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2017to Sep 2018
- 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have completed study SOM-012 and been categorized as a "responder"
- the subject agrees to participation by signing an informed consent statement
Who cannot join
- medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk
Trial locations and contacts
1 site in 1 country.
United States1 site
California Center for Sleep Disorders
Alameda, California, 94501
About this study
Official title: Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- continuous negative external pressure
- 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.
continuous negative external pressureDevice
Also called cNEP
continuous negative external pressure will be applied to the anterior neck at night
| Study group | Role | What they receive |
|---|---|---|
| cNEP | Experimental | continuous negative external pressure will be used nightly by all participants Receives: Device: continuous negative external pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in baseline apnea hypopnea index from baseline
Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr
Measured: End of Week 2 of home use
Secondary outcomes (2)
Collection of adverse events
Collection of adverse events
Measured: two week study period
Apnea hypopnea index, as measured by home sleep testing
Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startOct 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: no eligible subjects were available for recruitment
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerrold Kram, MD, Principal investigator, California Center for Sleep Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108417
- Sponsor's protocol ID
- SOM-013
- Status last verified
- Nov 2017
- First submitted
- 25 Mar 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"
- ClinicalTrials.gov ID
- NCT03108417
- Acronym / sponsor ID
- SOM-013
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no eligible subjects were available for recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 11 Apr 2017 (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.
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cNEP | Experimental | Device: continuous negative external pressurecontinuous negative external pressure will be used nightly by all participants |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must have completed study SOM-012 and been categorized as a "responder"
- the subject agrees to participation by signing an informed consent statement
Key exclusion criteria (1 listed)
- medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk
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 |
|---|---|---|
| continuous negative external pressureAlso: cNEPcontinuous negative external pressure will be applied to the anterior neck at night | Device | cNEP |
Primary outcome
Reduction in baseline apnea hypopnea index from baseline
Time frame: End of Week 2 of home use
Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr
2 secondary outcomes
Collection of adverse events
Time frame: two week study period
Apnea hypopnea index, as measured by home sleep testing
Time frame: two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jerrold Kram, MD principal investigator
California Center for Sleep Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous negative external pressure in people with Obstructive Sleep Apnea, run by Sommetrics, Inc. at 1 site 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Reduction in baseline apnea hypopnea index from baseline (time frame: End of Week 2 of home use). 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 Nov 2017.