Back to resultscNEP for the Treatment of Obstructive Sleep Apnea (cNEP)
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
cNEP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring obstructive sleep apnea, sleep apnea, OSA, cNEP, continuous negative external pressure
Eligibility Criteria
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
Sites / Locations
- Toronto Sleep Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cNEP
Arm Description
Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks
Outcomes
Primary Outcome Measures
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
A response (either initial or sustained) is defined as an AHI that is < 50% of the qualifying PSG (polysomnography) that is also < 15/hr
occurrence of adverse events
Adverse events that occur during the three weeks of cNEP home use.
Secondary Outcome Measures
"Initial Response" of AHI at PSG I
An AHI (apnea hypopnea index) that is <50% of that of the qualifying PSG, and <15/hr at PSG I, with cNEP in place.
Comparison of AHI at PSG I and PSG II
The AHI determined at PSG II will be compared with that of PSG I
time of SpO2 (oxygen saturation) < 90%
the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place
hours of home use of cNEP per night
the number of hours of each night at home that the subject uses cNEP
Three CGI (clinical global impression) subjective measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02677168
Brief Title
cNEP for the Treatment of Obstructive Sleep Apnea
Acronym
cNEP
Official Title
Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sommetrics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
obstructive sleep apnea, sleep apnea, OSA, cNEP, continuous negative external pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cNEP
Arm Type
Experimental
Arm Description
Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks
Intervention Type
Device
Intervention Name(s)
cNEP
Intervention Description
continuous negative external pressure
Primary Outcome Measure Information:
Title
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
Description
A response (either initial or sustained) is defined as an AHI that is < 50% of the qualifying PSG (polysomnography) that is also < 15/hr
Time Frame
three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
Title
occurrence of adverse events
Description
Adverse events that occur during the three weeks of cNEP home use.
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
"Initial Response" of AHI at PSG I
Description
An AHI (apnea hypopnea index) that is <50% of that of the qualifying PSG, and <15/hr at PSG I, with cNEP in place.
Time Frame
up to 12 months after the qualifying PSG
Title
Comparison of AHI at PSG I and PSG II
Description
The AHI determined at PSG II will be compared with that of PSG I
Time Frame
three weeks
Title
time of SpO2 (oxygen saturation) < 90%
Description
the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place
Time Frame
during each of the overnight PSGs
Title
hours of home use of cNEP per night
Description
the number of hours of each night at home that the subject uses cNEP
Time Frame
three weeks after initiation of home cNEP
Title
Three CGI (clinical global impression) subjective measures
Description
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.
Time Frame
three weeks after the initiation of home cNEP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Blackman, MD
Organizational Affiliation
Toronto Sleep Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Sleep Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
cNEP for the Treatment of Obstructive Sleep Apnea
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