NCT02767843

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 24, 2017

Completed
Last Updated

May 7, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

May 9, 2016

Results QC Date

January 9, 2017

Last Update Submit

April 15, 2024

Conditions

Snoring

Outcome Measures

Primary Outcomes (2)

  • Response

    snoring decreased by \<50% from baseline

    one night

  • Adverse Events

    all adverse events

    one night

Secondary Outcomes (1)

  • Complete Response

    one night

Study Arms (1)

treatment

EXPERIMENTAL

continuous negative external pressure (cNEP) at various negative pressures

Device: continuous negative external pressure (cNEP)

Interventions

continuous negative external pressure (cNEP)DEVICE

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

treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Center for Sleep Disorders

Alameda, California, 94501, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to difficulty of recruitment. Technical problems with measurements, so data were uninterpretable.

Results Point of Contact

Title
Jerrold Kram, MD
Organization
California Center for Sleep Disorders
info@californiasleepcenters.com
510.263.3300

Study Officials

  • Jerrold Kram, MD

    California Center for Sleep Disorders, Alameda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

May 9, 2016

First Posted

May 10, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

May 7, 2024

Results First Posted

March 24, 2017

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)