Sleep Apnea, ObstructivecNEPNCT02677168
cNEP for the Treatment of Obstructive Sleep Apnea
A study testing cNEP in people with Sleep Apnea, Obstructive, run by Sommetrics, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- cNEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 3 Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
- on that PSG, AHI must be 10 - 50/hr and >80% of the apneas and hypopneas must be obstructive
- no significant changes in health, medications, or lifestyle since the qualifying PSG
Who cannot join
- previous major surgery, injury or radiation to the neck
- beard or excessive hair on the area of the neck where the collar will be applied
- carotid artery disease
- serious medical conditions
- pregnancy
- use of home oxygen
- silicone allergy
- sleep disturbance other than obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- cNEP
- Keywords
- obstructive sleep apnea, sleep apnea, OSA, cNEP, continuous negative external pressure
- 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.
cNEPDevice
continuous negative external pressure
| Study group | Role | What they receive |
|---|---|---|
| cNEP | Experimental | Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks Receives: Device: cNEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
A response (either initial or sustained) is defined as an AHI that is < 50% of the qualifying PSG (polysomnography) that is also < 15/hr
Measured: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
occurrence of adverse events
Adverse events that occur during the three weeks of cNEP home use.
Measured: three weeks
Secondary outcomes (5)
"Initial Response" of AHI at PSG I
An AHI (apnea hypopnea index) that is <50% of that of the qualifying PSG, and <15/hr at PSG I, with cNEP in place.
Measured: up to 12 months after the qualifying PSG
Comparison of AHI at PSG I and PSG II
The AHI determined at PSG II will be compared with that of PSG I
Measured: three weeks
time of SpO2 (oxygen saturation) < 90%
the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place
Measured: during each of the overnight PSGs
hours of home use of cNEP per night
the number of hours of each night at home that the subject uses cNEP
Measured: three weeks after initiation of home cNEP
Three CGI (clinical global impression) subjective measures
Seven-item Likert CGI scales of three subjective measures: 1) subject's view of cNEP vs CPAP, 2) overall satisfaction with cNEP, 3) bed partner's feelings about cNEP.
Measured: three weeks after the initiation of home cNEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startMay 2016
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Blackman, MD, Principal investigator, Toronto Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677168
- Sponsor's protocol ID
- SOM-015
- Acronym
- cNEP
- Status last verified
- Oct 2017
- First submitted
- 2 Feb 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02677168
- Acronym / sponsor ID
- cNEP / SOM-015
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- obstructive sleep apnea, sleep apnea, OSA, cNEP, continuous negative external pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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 purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
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: cNEPSubjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
- on that PSG, AHI must be 10 - 50/hr and >80% of the apneas and hypopneas must be obstructive
- no significant changes in health, medications, or lifestyle since the qualifying PSG
Key exclusion criteria (8 listed)
- previous major surgery, injury or radiation to the neck
- beard or excessive hair on the area of the neck where the collar will be applied
- carotid artery disease
- serious medical conditions
- pregnancy
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 |
|---|---|---|
| cNEPcontinuous negative external pressure | Device | cNEP |
Primary outcome
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
Time frame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
A response (either initial or sustained) is defined as an AHI that is < 50% of the qualifying PSG (polysomnography) that is also < 15/hr
occurrence of adverse events
Time frame: three weeks
Adverse events that occur during the three weeks of cNEP home use.
5 secondary outcomes
"Initial Response" of AHI at PSG I
Time frame: up to 12 months after the qualifying PSG
Comparison of AHI at PSG I and PSG II
Time frame: three weeks
time of SpO2 (oxygen saturation) < 90%
Time frame: during each of the overnight PSGs
hours of home use of cNEP per night
Time frame: three weeks after initiation of home cNEP
Three CGI (clinical global impression) subjective measures
Time frame: three weeks after the initiation of home cNEP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- 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.
Adam Blackman, MD principal investigator
Toronto Sleep Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cNEP in people with Sleep Apnea, Obstructive, run by Sommetrics, Inc. at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 18 Apr 2018. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II (time frame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I). 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 18 Apr 2018.