Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
NCT ID: NCT03375905
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2017-12-07
2019-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cNEP
cNEP treatment
cNEP
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Interventions
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cNEP
subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* abnormalities in neck structure
* sleep disturbance other than obstructive sleep apnea
* serious medical illness
* pregnancy
18 Years
70 Years
ALL
No
Sponsors
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Sommetrics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jamil S Sulieman, MD
Role: PRINCIPAL_INVESTIGATOR
The Sleep Lab, Kaneohe, HI
Locations
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The Sleep Lab
Kaneohe, Hawaii, United States
Countries
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Other Identifiers
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SOM-014
Identifier Type: -
Identifier Source: org_study_id
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