Pilot Study of cNEP for the Treatment of Snoring

NCT ID: NCT02767843

Last Updated: 2024-05-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Snoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

continuous negative external pressure (cNEP) at various negative pressures

Group Type EXPERIMENTAL

continuous negative external pressure (cNEP)

Intervention Type DEVICE

soft silicone collar placed on the anterior neck, to which a negative pressure is introduced

Interventions

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continuous negative external pressure (cNEP)

soft silicone collar placed on the anterior neck, to which a negative pressure is introduced

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sommetrics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerrold Kram, MD

Role: PRINCIPAL_INVESTIGATOR

California Center for Sleep Disorders, Alameda, CA

Locations

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California Center for Sleep Disorders

Alameda, California, United States

Site Status

Countries

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United States

Other Identifiers

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SOM-011

Identifier Type: -

Identifier Source: org_study_id

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