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Completed

NCT Number: NCT02677168

cNEP for the Treatment of Obstructive Sleep Apnea

The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
  • on that PSG, AHI must be 10 - 50/hr and >80% of the apneas and hypopneas must be obstructive
  • no significant changes in health, medications, or lifestyle since the qualifying PSG

Key Exclusion Criteria:

  • previous major surgery, injury or radiation to the neck
  • beard or excessive hair on the area of the neck where the collar will be applied
  • carotid artery disease
  • serious medical conditions
  • pregnancy
  • use of home oxygen
  • silicone allergy
  • sleep disturbance other than obstructive sleep apnea

Treatment and study plan

cNEP

Device

continuous negative external pressure

Primary outcomes

  1. "Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II

    Time frame: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I

    A response (either initial or sustained) is defined as an AHI that is < 50% of the qualifying PSG (polysomnography) that is also < 15/hr

  2. occurrence of adverse events

    Time frame: three weeks

    Adverse events that occur during the three weeks of cNEP home use.

Secondary outcomes

  1. "Initial Response" of AHI at PSG I

    Time frame: up to 12 months after the qualifying PSG

    An AHI (apnea hypopnea index) that is <50% of that of the qualifying PSG, and <15/hr at PSG I, with cNEP in place.

  2. Comparison of AHI at PSG I and PSG II

    Time frame: three weeks

    The AHI determined at PSG II will be compared with that of PSG I

  3. time of SpO2 (oxygen saturation) < 90%

    Time frame: during each of the overnight PSGs

    the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place

  4. hours of home use of cNEP per night

    Time frame: three weeks after initiation of home cNEP

    the number of hours of each night at home that the subject uses cNEP

  5. Three CGI (clinical global impression) subjective measures

    Time frame: three weeks after the initiation of home cNEP

    Seven-item Likert CGI scales of three subjective measures: 1) subject's view of cNEP vs CPAP, 2) overall satisfaction with cNEP, 3) bed partner's feelings about cNEP.

Sponsors and collaborators

Lead sponsor

Sommetrics, Inc.

Industry

Registry information

Official study title

Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)

Acronym: cNEP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2016
Registry last updated
Apr 18, 2018

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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