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

NCT05954026 | Recruiting

• 1 other identifier: OVEN-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep apnea; MAD; positive expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.

  To demonstrate that the ExVent Accessory (inserted into the O2Vent Optima device) is safe and effective in treating mild to moderate OSA. Statistically significant change in AHI with use of the O2Vent Optima + ExVent compared to baseline AHI value (i.e., no treatment).

  Two Years

Secondary Outcomes (1)

• Adverse events will be summarized descriptively in terms of type and frequency

  Two years

Study Arms (1)

Single arm

OTHER

Prospective, open label, single-arm multicenter study

Device: ExVent

Interventions

ExVent DEVICE

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

Single arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject aged 22 years or older.
• Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea.
• Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week).
• Subject completed initial fitting optimization of the O2Vent Optima device.
• Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
• Must be able to comply with all study requirements as outlined in the protocol.

You may not qualify if:

• Male or female subject aged 22 years or older.
• Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea.
• Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week).
• Subject completed initial fitting optimization of the O2Vent Optima device.
• Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
• Must be able to comply with all study requirements as outlined in the protocol.
• Oral cavity infection or any other oral or dental condition or problem that would limit patient use of the O2Vent Optima oral appliance.
• Any concomitant diagnosed or suspected sleep disorder including insomnia or central apnea.
• History of any prior OSA surgical treatments including RF ablation treatment or palatal stent devices.
• Concomitant use of any other prescription device for treatment of OSA.
• Female of child-bearing age who is pregnant or intending to become pregnant during the study participation period.
• Subject with significant change in weight since completion of the diagnostic baseline PSG study (i.e., ±10% or greater change in total body weight.
• Subject on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
• Subject who consumes \> 500 mg caffeine per day (e.g., \> 8 cola-type beverages, \> 5 cups of coffee).
• Subject who consumes \> 3 alcoholic drinks/day.

Sponsors & Collaborators

• Centre for Sleep and Chronobiology, Canada: lead

Study Sites (1)

Centre for Sleep and Chronobiology

Toronto, Ontario, M5P 2X7, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sat Sharma

  Centre for Sleep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sat Sharma

CONTACT

6479817732; ssharma@mts.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Prospective, open label, single-arm multicenter study

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: December 15, 2021
• Primary Completion: December 8, 2024
• Study Completion: March 10, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)