Recruiting

ExVent with O2Vent

Sponsor:

Centre for Sleep and Chronobiology, Canada

Code:

NCT05954026

Conditions

Sleep Apnea, Obstructive

Sleep-Disordered Breathing

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ExVent

Study Details

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

Study ID

NCT05954026

Start date

Dec 15, 2021

Status verified date

Feb, 2024

Completion date

Mar 10, 2025

Anticipated

Primary completion date

Dec 8, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female subject aged 22 years or older.
2. 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.
3. 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).
4. Subject completed initial fitting optimization of the O2Vent Optima device.
5. Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
6. Must be able to comply with all study requirements as outlined in the protocol.

Exclusion Criteria:

Inclusion Criteria:

1. Male or female subject aged 22 years or older.
2. 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.
3. 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).
4. Subject completed initial fitting optimization of the O2Vent Optima device.
5. Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
6. Must be able to comply with all study requirements as outlined in the protocol.

Exclusion Criteria:

1. Oral cavity infection or any other oral or dental condition or problem that would limit patient use of the O2Vent Optima oral appliance.
2. Any concomitant diagnosed or suspected sleep disorder including insomnia or central apnea.
3. History of any prior OSA surgical treatments including RF ablation treatment or palatal stent devices.
4. Concomitant use of any other prescription device for treatment of OSA.
5. Female of child-bearing age who is pregnant or intending to become pregnant during the study participation period.
6. Subject with significant change in weight since completion of the diagnostic baseline PSG study (i.e., ±10% or greater change in total body weight.
7. Subject on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
8. Subject who consumes > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee).
9. Subject who consumes > 3 alcoholic drinks/day.
10. Subject currently enrolled in any other research study.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single arm

Prospective, open label, single-arm multicenter study

Interventions

ExVent

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

Primary outcome measure

  • Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent. [ Time Frame: Two Years ]

Central Contacts and Locations

Central contacts

Locations

Centre for Sleep and Chronobiology

Recruiting

Toronto, Ontario, Canada, M5P 2X7

Contacts

More Information

Sponsor

Centre for Sleep and Chronobiology, Canada

Last update posted

Feb 6, 2024

Last verified

Feb, 2024

Keywords

  • Sleep apnea
  • MAD
  • positive expiratory pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Sleep and Chronobiology, Canada on 2024-02-06.