Status:
COMPLETED
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
Lead Sponsor:
Sommetrics, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03375905
Start Date
December 7 2017
End Date
April 26 2019
Last Update
September 19 2019
Active Locations (1)
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1
The Sleep Lab
Kaneohe, Hawaii, United States, 96744