Using a new accessory with an oral device to treat obstructive sleep apnea

Oventus ExVent Accessory to the O2Vent Optima Device

This study is testing a new accessory that works with an oral device to see if it can help people with mild to moderate obstructive sleep apnea breathe better while they sleep.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Centre for Sleep and Chronobiology, Canada (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05954026 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the ExVent accessory used with the O2Vent Optima oral appliance to treat obstructive sleep apnea (OSA). The ExVent provides oral Expiratory Positive Airway Pressure (EPAP) to support the upper airway, similar to existing nasal EPAP devices. The study is a prospective, open-label, single-arm trial involving up to 30 subjects diagnosed with mild to moderate OSA. Participants will use the device at home after confirming their diagnosis through a polysomnography (PSG) study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 years or older who have been diagnosed with mild to moderate OSA and are compliant users of the O2Vent Optima device.

Not a fit: Patients with severe obstructive sleep apnea or those who are not compliant with their current sleep apnea therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment options for patients with mild to moderate obstructive sleep apnea.

How similar studies have performed: While nasal EPAP devices have shown success, the use of oral EPAP with the ExVent accessory is a novel approach that has not been extensively tested.

Eligibility 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:

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.

Where this trial is running

Toronto, Ontario

• Centre for Sleep and Chronobiology — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Sat Sharma — Centre for Sleep
• Study coordinator: Sat Sharma

Conditions Sleep Apnea, Obstructive; Sleep-Disordered Breathing; Sleep apnea; MAD; positive expiratory pressure