Pilot Study of cNEP for the Treatment of Snoring

Pilot Study to Assess the Effectiveness and Safety of Continuous Negative External Pressure (cNEP) in Reducing Respiratory Sounds in Individuals With Chronic Snoring

This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.

Study Overview

• Status: Terminated
• Conditions: Snoring
• Intervention / Treatment: Device: continuous negative external pressure (cNEP)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Alameda, California, United States, 94501
      • California Center for Sleep Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• sleep test within the previous six months that shows snoring of at least 30 dB for at least 30% of total sleep time
• AHI < 10/hr

Exclusion Criteria:

• previous neck surgery or radiation
• carotid artery disease
• serious medical or psychiatric illness
• pregnancy
• silicone allergy
• excessive use of alcohol or sedating drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; continuous negative external pressure (cNEP) at various negative pressures	Device: continuous negative external pressure (cNEP); soft silicone collar placed on the anterior neck, to which a negative pressure is introduced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response	snoring decreased by <50% from baseline	one night
Adverse Events	all adverse events	one night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response	snoring for < 5% of total sleep tim	one night

Collaborators and Investigators

• Sponsor: Sommetrics, Inc.
• Investigators: Principal Investigator: Jerrold Kram, MD, California Center for Sleep Disorders, Alameda, CA

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: SOM-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED