cNEP for the Treatment of Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— cNEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677168
• Other study ID #: SOM-015
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: April 17, 2018
• Start date: May 2016
• Est. completion date: November 3, 2017

Study information

• Verified date: October 2017
• Source: Sommetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• cNEP
continuous negative external pressure

Locations

Country	Name	City	State
Canada	Toronto Sleep Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sommetrics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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	three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
Primary	occurrence of adverse events	Adverse events that occur during the three weeks of cNEP home use.	three weeks
Secondary	"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.	up to 12 months after the qualifying PSG
Secondary	Comparison of AHI at PSG I and PSG II	The AHI determined at PSG II will be compared with that of PSG I	three weeks
Secondary	time of SpO2 (oxygen saturation) < 90%	the number of minutes during the overnight PSG when SpO2 is < 90% with cNEP in place	during each of the overnight PSGs
Secondary	hours of home use of cNEP per night	the number of hours of each night at home that the subject uses cNEP	three weeks after initiation of home cNEP
Secondary	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.	three weeks after the initiation of home cNEP