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Use of the ExVent Accessory With the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea

NCT05954026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-06

No results posted yet for this study

Summary

The ExVent is an optional accessory to the O2Vent Optima MAD and provides oral Expiratory Positive Airway Pressure (EPAP). Oral EPAP with the ExVent is designed to provide upper airway support via similar mechanisms of action of nasal EPAP devices in commercial distribution, e.g., passive dilatation of the airway, which reduces flow limitation. Nasal EPAP devices are in commercial distribution as stand-alone therapies for the treatment of OSA. The oral EPAP provided by the ExVent accessory is designed to augment the OSA therapy provided by the O2Vent Optima.

Conditions

  • Sleep Apnea, Obstructive
  • Sleep-Disordered Breathing

Interventions

DEVICE

ExVent

ExVent Accessory (inserted into the O2Vent Optima device) for treatment of sleep apnea

Sponsors & Collaborators

  • Centre for Sleep and Chronobiology, Canada

    lead OTHER

Principal Investigators

  • Sat Sharma · Centre for Sleep

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-12-08
Completion
2025-03-10

Countries

  • Canada

Study Locations

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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 NCT05954026 on ClinicalTrials.gov