Sleep Apnea, ObstructiveNCT05954026
Use of the ExVent Accessory With the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea
A study testing ExVent in people with Sleep Apnea, Obstructive and Sleep-Disordered Breathing, run by Centre for Sleep and Chronobiology, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep-Disordered Breathing
- What is being tested?
- ExVent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2021to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject currently enrolled in any other research study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Sleep and Chronobiology
Toronto, Ontario, M5P 2X7
Satyendra Sharma, MD, 6479817732, ssharma@mts.net
Terence Kwang, 14168973568, t.kwang@sleepmed.ca
About this study
Official title: Oventus ExVent Accessory to the O2Vent Optima Device
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.
Read the detailed description
Title Use of the ExVent Accessory with the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea
Investigational Device Oventus Medical ExVent Accessory (inserted into the O2Vent Optima device)
Investigator Study Sites Up to 3 investigational sites
Regulatory Status This is a non-significant risk investigational device exemption (IDE) clinical trial. FDA approval is not required, but IRB review and approval are required.
Study Design Prospective, open label, single-arm multicenter study Sample Size Up to thirty (30) subjects will be enrolled to yield a minimum of 20 evaluable subjects (mITT subjects).
Study Objective To demonstrate that the ExVent Accessory (inserted into the O2Vent Optima device) is safe and effective in treating mild to moderate OSA Patient Population Patients who have been diagnosed with mild to moderate OSA (i.e., AHI ≥ 5 and ≤ 30)
Study Overview Study Design/ Duration:
This is a prospective, open-label, single-arm study conducted at up to 3 sites. Site participation is expected to be approximately 6 months from first subject enrollment until completion of the last study visit.
Screening Phase
- Confirm subject meets all inclusion and exclusion criteria
- In the absence of a prior diagnostic PSG study within the last 6 months at the investigational site's sleep lab, subject will complete a PSG study to obtain the baseline AHI and confirm a diagnosis of mild to moderate OSA
Home Use Phase
- Subject uses the O2Vent Optima + ExVent for up to 3 months and logs usage hours.
PSG Night Subjects who successfully complete* the Home Use Phase will have an in-lab PSG sleep night while using the O2Vent Optima + ExVent
Primary Effectiveness Outcome Measure Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.
Primary Effectiveness Endpoint Statistically significant change in AHI with use of the O2Vent Optima + ExVent compared to baseline AHI value (i.e., no treatment).
Safety Outcome Measure Adverse events will be summarized descriptively in terms of type and frequency
Statistical Analysis This clinical trial is designed to determine whether the concomitant use of the O2Vent + ExVent devices results in a statistically significant reduction in AHI from the baseline value for each subject. A paired t-test will be used for this comparison.
A sample size calculation is based on data from a comparable group of patients (Lai, 2019), where it was determined that the mean change in AHI from baseline was -8.37, with a standard deviation of the paired differences of 7.73.
Setting alpha=0.05 and power=0.80, the calculated sample size is 9 subjects. Because of the imperfect predictability of historical data, to ensure adequate power this study will enroll 20 evaluable patients.
The mITT population will be used for this analysis**
- Being tested
- ExVent
- Keywords
- Sleep apnea, MAD, positive expiratory pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExVentDevice
ExVent Accessory (inserted into the O2Vent Optima device) for treatment of sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Prospective, open label, single-arm multicenter study Receives: Device: ExVent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two Years
Secondary outcomes (1)
Adverse events will be summarized descriptively in terms of type and frequency
Adverse events which might occur or have been known to occur with Mandibular Advancement devices include but are not limited to the following:
- Tooth movement, discomfort, pain or changes in dental occlusion
- Loss of dental restorations
- Dental soreness
- Pain or soreness to the temporomandibular joint
- Excessive salivation
- Cheek or tongue pain
- Jaw discomfort, pain or jaw set
- Gingivitis
- Dry mouth
- Difficulty sleeping
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start15 Dec 2021
- Primary completion8 Dec 2024 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Prospective, open label, single-arm multicenter study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Sleep and Chronobiology, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sat Sharma, Centre for Sleep and Chronobiology, Canada
- Investigators
- Sat Sharma, Principal investigator, Centre for Sleep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954026
- Sponsor's protocol ID
- OVEN-02
- Status last verified
- Feb 2024
- First submitted
- 12 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oventus ExVent Accessory to the O2Vent Optima Device
- ClinicalTrials.gov ID
- NCT05954026
- Acronym / sponsor ID
- OVEN-02
- Keywords
- Sleep apnea, MAD, positive expiratory pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre for Sleep and Chronobiology, CanadaUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 8 Dec 2024 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title Use of the ExVent Accessory with the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea
Investigational Device Oventus Medical ExVent Accessory (inserted into the O2Vent Optima device)
Investigator Study Sites Up to 3 investigational sites
Regulatory Status This is a non-significant risk investigational device exemption (IDE) clinical trial. FDA approval is not required, but IRB review and approval are required.
Study Design Prospective, open label, single-arm multicenter study Sample Size Up to thirty (30) subjects will be enrolled to yield a minimum of 20 evaluable subjects (mITT subjects).
Study Objective To demonstrate that the ExVent Accessory (inserted into the O2Vent Optima device) is safe and effective in treating mild to moderate OSA Patient Population Patients who have been diagnosed with mild to moderate OSA (i.e., AHI ≥ 5 and ≤ 30)
Study Overview Study Design/ Duration:
This is a prospective, open-label, single-arm study conducted at up to 3 sites. Site participation is expected to be approximately 6 months from first subject enrollment until completion of the last study visit.
Screening Phase
- Confirm subject meets all inclusion and exclusion criteria
- In the absence of a prior diagnostic PSG study within the last 6 months at the investigational site's sleep lab, subject will complete a PSG study to obtain the baseline AHI and confirm a diagnosis of mild to moderate OSA
Home Use Phase
- Subject uses the O2Vent Optima + ExVent for up to 3 months and logs usage hours.
PSG Night Subjects who successfully complete* the Home Use Phase will have an in-lab PSG sleep night while using the O2Vent Optima + ExVent
Primary Effectiveness Outcome Measure Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.
Primary Effectiveness Endpoint Statistically significant change in AHI with use of the O2Vent Optima + ExVent compared to baseline AHI value (i.e., no treatment).
Safety Outcome Measure Adverse events will be summarized descriptively in terms of type and frequency
Statistical Analysis This clinical trial is designed to determine whether the concomitant use of the O2Vent + ExVent devices results in a statistically significant reduction in AHI from the baseline value for each subject. A paired t-test will be used for this comparison.
A sample size calculation is based on data from a comparable group of patients (Lai, 2019), where it was determined that the mean change in AHI from baseline was -8.37, with a standard deviation of the paired differences of 7.73.
Setting alpha=0.05 and power=0.80, the calculated sample size is 9 subjects. Because of the imperfect predictability of historical data, to ensure adequate power this study will enroll 20 evaluable patients.
The mITT population will be used for this analysis**
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open label, single-arm multicenter study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: ExVentProspective, open label, single-arm multicenter study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExVentExVent Accessory (inserted into the O2Vent Optima device) for treatment of sleep apnea | Device | Single arm |
Primary outcome
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
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).
1 secondary outcome
Adverse events will be summarized descriptively in terms of type and frequency
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sat Sharma principal investigator
Centre for Sleep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExVent in people with Sleep Apnea, Obstructive and Sleep-Disordered Breathing, run by Centre for Sleep and Chronobiology, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sat Sharma (6479817732, ssharma@mts.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.