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Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03375905
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sommetrics, Inc.

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: cNEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. proportion of sustained responders [ Time Frame: two weeks after initiation of treatment ]
    reduction of AHI of >50% and to <15/hr from qualifying PSG


Secondary Outcome Measures :
  1. proportion of initial responders [ Time Frame: at PSG 1, one day ]
    reduction of AHI of >50% and to <15/hr from qualifying PSG

  2. AHI comparison with qualifying PSG [ Time Frame: one day, on three separate study occasions ]
    apnea-hypopnea index

  3. ODI comparison with qualifying PSG [ Time Frame: one day, on three separate study occasions ]
    oxygen desaturation index

  4. SpO2 <90% comparison with qualifying PSG [ Time Frame: one day, on three separate study occasions ]
    oxygen desaturation index <90%

  5. 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

  6. CGI of satisfaction with the cNEP device [ Time Frame: after two weeks of treatment ]
    clinical global impressions of the cNEP device

  7. 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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Mary Ellen Lau 808.234.0033 thesleeplabof@aol.com

Locations
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United States, Hawaii
The Sleep Lab Recruiting
Kaneohe, Hawaii, United States, 96744
Contact: Mary Ellen Lau    808-234-0033    thesleeplabof@aol.com   
Sponsors and Collaborators
Sommetrics, Inc.
Investigators
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Principal Investigator: Jamil S Sulieman, MD The Sleep Lab, Kaneohe, HI

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Responsible Party: Sommetrics, Inc.
ClinicalTrials.gov Identifier: NCT03375905     History of Changes
Other Study ID Numbers: SOM-014
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Sommetrics, Inc.:
ethnic Japanese

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases