Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
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ClinicalTrials.gov Identifier: NCT03375905 |
Recruitment Status :
Completed
First Posted : December 18, 2017
Last Update Posted : September 19, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Device: cNEP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | December 7, 2017 |
Actual Primary Completion Date : | March 28, 2019 |
Actual Study Completion Date : | April 26, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: cNEP
cNEP treatment
|
Device: cNEP
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Other Name: continuous negative external pressure |
- proportion of sustained responders [ Time Frame: two weeks after initiation of treatment ]reduction of AHI of >50% and to <15/hr from qualifying PSG
- proportion of initial responders [ Time Frame: at PSG 1, one day ]reduction of AHI of >50% and to <15/hr from qualifying PSG
- AHI comparison with qualifying PSG [ Time Frame: one day, on three separate study occasions ]apnea-hypopnea index
- ODI comparison with qualifying PSG [ Time Frame: one day, on three separate study occasions ]oxygen desaturation index
- SpO2 <90% comparison with qualifying PSG [ Time Frame: one day, on three separate study occasions ]oxygen desaturation index <90%
- CGI of sleep [ Time Frame: three months, and two weeks, respectively ]clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
- CGI of satisfaction with the cNEP device [ Time Frame: after two weeks of treatment ]clinical global impressions of the cNEP device
- Treatment-emergent adverse events [ Time Frame: two weeks ]tabulation of treatment-emergent adverse events

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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:
- BMI >34
- abnormalities in neck structure
- sleep disturbance other than obstructive sleep apnea
- serious medical illness
- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375905
United States, Hawaii | |
The Sleep Lab | |
Kaneohe, Hawaii, United States, 96744 |
Principal Investigator: | Jamil S Sulieman, MD | The Sleep Lab, Kaneohe, HI |
Responsible Party: | Sommetrics, Inc. |
ClinicalTrials.gov Identifier: | NCT03375905 |
Other Study ID Numbers: |
SOM-014 |
First Posted: | December 18, 2017 Key Record Dates |
Last Update Posted: | September 19, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
ethnic Japanese |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |