Obstructive Sleep ApneaNCT03375905
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
A study testing cNEP in people with Obstructive Sleep Apnea, run by Sommetrics, Inc. at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- cNEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2017to 26 Apr 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both parents ethnically Japanese, or one parent Japanese and the other east-Asian
- PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and <80% of apneas and hypopneas are obstructive
- cNEP collar fits and is well-tolerated
Who cannot join
- BMI >34
- abnormalities in neck structure
- sleep disturbance other than obstructive sleep apnea
- serious medical illness
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)
The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- cNEP
- Keywords
- ethnic Japanese
- 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.
cNEPDevice
Also called continuous negative external pressure
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
| Study group | Role | What they receive |
|---|---|---|
| cNEP | Experimental | cNEP treatment Receives: Device: cNEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of sustained responders
reduction of AHI of >50% and to <15/hr from qualifying PSG
Measured: two weeks after initiation of treatment
Secondary outcomes (7)
proportion of initial responders
reduction of AHI of >50% and to <15/hr from qualifying PSG
Measured: at PSG 1, one day
AHI comparison with qualifying PSG
apnea-hypopnea index
Measured: one day, on three separate study occasions
ODI comparison with qualifying PSG
oxygen desaturation index
Measured: one day, on three separate study occasions
SpO2 <90% comparison with qualifying PSG
oxygen desaturation index <90%
Measured: one day, on three separate study occasions
CGI of sleep
clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
Measured: three months, and two weeks, respectively
CGI of satisfaction with the cNEP device
clinical global impressions of the cNEP device
Measured: after two weeks of treatment
Treatment-emergent adverse events
tabulation of treatment-emergent adverse events
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 posted18 Dec 2017
- Study start7 Dec 2017
- Primary completion28 Mar 2019
- Study completion26 Apr 2019
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sommetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamil S Sulieman, MD, Principal investigator, The Sleep Lab, Kaneohe, HI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375905
- Sponsor's protocol ID
- SOM-014
- Status last verified
- Sep 2019
- First submitted
- 7 Dec 2017
- Last updated
- 19 Sep 2019
- 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03375905
- Acronym / sponsor ID
- SOM-014
- Conditions
- Obstructive Sleep Apnea
- Keywords
- ethnic Japanese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sommetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 18 Dec 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.
The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.
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: cNEPcNEP treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both parents ethnically Japanese, or one parent Japanese and the other east-Asian
- PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and <80% of apneas and hypopneas are obstructive
- cNEP collar fits and is well-tolerated
Key exclusion criteria (5 listed)
- BMI >34
- abnormalities in neck structure
- sleep disturbance other than obstructive sleep apnea
- serious medical illness
- 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 |
|---|---|---|
| cNEPAlso: continuous negative external pressuresubjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas | Device | cNEP |
Primary outcome
proportion of sustained responders
Time frame: two weeks after initiation of treatment
reduction of AHI of >50% and to <15/hr from qualifying PSG
7 secondary outcomes
proportion of initial responders
Time frame: at PSG 1, one day
AHI comparison with qualifying PSG
Time frame: one day, on three separate study occasions
ODI comparison with qualifying PSG
Time frame: one day, on three separate study occasions
SpO2 <90% comparison with qualifying PSG
Time frame: one day, on three separate study occasions
CGI of sleep
Time frame: three months, and two weeks, respectively
CGI of satisfaction with the cNEP device
Time frame: after two weeks of treatment
Treatment-emergent adverse events
Time frame: two weeks
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 19 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Jamil S Sulieman, MD principal investigator
The Sleep Lab, Kaneohe, HI
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 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 3 inclusion and 5 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 19 Sep 2019. 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 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?
proportion of sustained responders (time frame: two weeks after initiation of treatment). 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 19 Sep 2019.