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

Primary Purpose

Sleep Apnea, Obstructive, Sleep-Disordered Breathing

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ExVent
Sponsored by
Centre for Sleep and Chronobiology, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep apnea, MAD, positive expiratory pressure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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. Subject currently enrolled in any other research study.

Sites / Locations

  • Centre for Sleep and ChronobiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Prospective, open label, single-arm multicenter study

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 12, 2023
Last Updated
July 20, 2023
Sponsor
Centre for Sleep and Chronobiology, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05954026
Brief Title
Use of the ExVent Accessory With the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea
Official Title
Oventus ExVent Accessory to the O2Vent Optima Device
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Sleep and Chronobiology, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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 1. 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**

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Sleep-Disordered Breathing
Keywords
Sleep apnea, MAD, positive expiratory pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Prospective, open label, single-arm multicenter study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Prospective, open label, single-arm multicenter study
Intervention Type
Device
Intervention Name(s)
ExVent
Intervention Description
ExVent Accessory (inserted into the O2Vent Optima device) for treatment of sleep apnea
Primary Outcome Measure Information:
Title
Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.
Description
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).
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Adverse events will be summarized descriptively in terms of type and frequency
Description
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
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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. Subject currently enrolled in any other research study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sat Sharma
Phone
6479817732
Email
ssharma@mts.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sat Sharma
Organizational Affiliation
Centre for Sleep
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Sleep and Chronobiology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5P 2X7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satyendra Sharma, MD
Phone
6479817732
Email
ssharma@mts.net
First Name & Middle Initial & Last Name & Degree
Terence Kwang
Phone
14168973568
Email
t.kwang@sleepmed.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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