Back to resultsEffectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cNEP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring ethnic Japanese
Eligibility Criteria
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
Sites / Locations
- The Sleep Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cNEP
Arm Description
cNEP treatment
Outcomes
Primary Outcome Measures
proportion of sustained responders
reduction of AHI of >50% and to <15/hr from qualifying PSG
Secondary Outcome Measures
proportion of initial responders
reduction of AHI of >50% and to <15/hr from qualifying PSG
AHI comparison with qualifying PSG
apnea-hypopnea index
ODI comparison with qualifying PSG
oxygen desaturation index
SpO2 <90% comparison with qualifying PSG
oxygen desaturation index <90%
CGI of sleep
clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
CGI of satisfaction with the cNEP device
clinical global impressions of the cNEP device
Treatment-emergent adverse events
tabulation of treatment-emergent adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03375905
Brief Title
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sommetrics, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
ethnic Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cNEP
Arm Type
Experimental
Arm Description
cNEP treatment
Intervention Type
Device
Intervention Name(s)
cNEP
Other Intervention Name(s)
continuous negative external pressure
Intervention Description
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Primary Outcome Measure Information:
Title
proportion of sustained responders
Description
reduction of AHI of >50% and to <15/hr from qualifying PSG
Time Frame
two weeks after initiation of treatment
Secondary Outcome Measure Information:
Title
proportion of initial responders
Description
reduction of AHI of >50% and to <15/hr from qualifying PSG
Time Frame
at PSG 1, one day
Title
AHI comparison with qualifying PSG
Description
apnea-hypopnea index
Time Frame
one day, on three separate study occasions
Title
ODI comparison with qualifying PSG
Description
oxygen desaturation index
Time Frame
one day, on three separate study occasions
Title
SpO2 <90% comparison with qualifying PSG
Description
oxygen desaturation index <90%
Time Frame
one day, on three separate study occasions
Title
CGI of sleep
Description
clinical global impressions of sleep, comparing 3-month baseline with end of two weeks of treatment
Time Frame
three months, and two weeks, respectively
Title
CGI of satisfaction with the cNEP device
Description
clinical global impressions of the cNEP device
Time Frame
after two weeks of treatment
Title
Treatment-emergent adverse events
Description
tabulation of treatment-emergent adverse events
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil S Sulieman, MD
Organizational Affiliation
The Sleep Lab, Kaneohe, HI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sleep Lab
City
Kaneohe
State/Province
Hawaii
ZIP/Postal Code
96744
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
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