cNEP for the Treatment of Obstructive Sleep Apnea

NCT02677168 | Completed

• 1 other identifier: SOM-015
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea, Obstructive

Keywords

obstructive sleep apnea; sleep apnea; OSA; cNEP; continuous negative external pressure

Outcome Measures

Primary Outcomes (2)

• "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

• occurrence of adverse events

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

  three weeks

Secondary Outcomes (5)

• "Initial Response" of AHI at PSG I

  up to 12 months after the qualifying PSG

• Comparison of AHI at PSG I and PSG II

  three weeks

• time of SpO2 (oxygen saturation) < 90%

  during each of the overnight PSGs

• hours of home use of cNEP per night

  three weeks after initiation of home cNEP

• Three CGI (clinical global impression) subjective measures

  three weeks after the initiation of home cNEP

Study Arms (1)

cNEP

EXPERIMENTAL

Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks

Device: cNEP

Interventions

cNEP DEVICE

continuous negative external pressure

cNEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sommetrics, Inc.: lead

Study Sites (1)

Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Adam Blackman, MD

  Toronto Sleep Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 9, 2016
• Study Start: May 1, 2016
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: April 18, 2018

Record last verified: 2017-10

Locations

CA (1)