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Safety, and Tolerability of the ZENS Device (PLUTO)

NCT04063917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-06-24

No results posted yet for this study

Summary

The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. The intended purpose of the investigational device is to deliver a transcutaneous electrical stimulation signal to the hypoglossal nerve in the "ON" phase in order to alter the apnea hypopnea index (AHI), as well as mean snoring burden (intensity, duration), and to deliver no signal in the "OFF" phase of the study as a means for comparison. Subjects utilizing the ZENS Device will experience a reduction in snoring during the "ON" versus "OFF" phase, as quantified by a reduction in the percentage of time per hour of snoring (≥40 dB) in the active ZENS Device ("ON" phase) versus the inactive ZENS Device ("OFF" phase).

Conditions

Interventions

DEVICE

ZENS

ZENS transcutaneous nerve stimulator (ZENS Device), a wearable and non-invasive device which stimulates nerves in the neck to reduce airway obstruction and maintain muscular tension while sleeping to reduce snoring severity.

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • Interior Health

    collaborator INDUSTRY

  • Zennea Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Marcus Povitz, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-04-01
Completion
2021-06-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063917 on ClinicalTrials.gov