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Completed

NCT Number: NCT03375905

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sleep Lab

Kaneohe, Hawaii, 96744, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cNEP

Device

subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas

Other names: continuous negative external pressure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sommetrics, Inc.

Industry

Registry information

Official study title

Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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