Your session is about to expire
← Back to Search
ExVent Accessory for Obstructive Sleep Apnea
N/A
Recruiting
Led By Sat Sharma
Research Sponsored by Centre for Sleep and Chronobiology, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject completed initial fitting optimization of the O2Vent Optima device
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
Study Summary
This trial evaluates the ExVent accessory for the O2Vent Optima MAD device, which helps reduce sleep apnea symptoms with oral EPAP.
Who is the study for?
This trial is for adults aged 22 or older with mild to moderate obstructive sleep apnea, who have been using the O2Vent Optima device regularly. Participants must not be in other studies, pregnant, or have conditions affecting oral appliance use. They should not have had significant weight changes recently and must avoid high caffeine or alcohol intake.Check my eligibility
What is being tested?
The study tests the ExVent accessory used with the O2Vent Optima mouthpiece for treating sleep apnea. The ExVent provides oral EPAP to support airways during sleep, potentially improving on existing nasal EPAP devices' mechanisms.See study design
What are the potential side effects?
While specific side effects are not listed here, similar devices can cause discomfort in the mouth or jaw, increased salivation or dryness, and potential irritation of oral tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed the initial fitting for the O2Vent Optima device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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.
Secondary outcome measures
Adverse events will be summarized descriptively in terms of type and frequency
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Prospective, open label, single-arm multicenter study
Find a Location
Who is running the clinical trial?
Centre for Sleep and Chronobiology, CanadaLead Sponsor
Sat SharmaPrincipal InvestigatorCentre for Sleep
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed the initial fitting for the O2Vent Optima device.I am a woman who could become pregnant and plan to during the study.You drink more than eight cola-type beverages or five cups of coffee every day.I am 22 years old or older.You drink more than 3 alcoholic drinks every day.You are using another prescription device to treat obstructive sleep apnea.You have gained or lost more than 10% of your body weight since the last diagnostic sleep study.I can stop using my sleep apnea treatments for up to 7 days.I am not on a stable dose of medication that could affect my sleep.I have or might have a sleep disorder like insomnia or central apnea.I have had surgery for sleep apnea, including RF ablation or used a palatal stent.I don't have any oral infections or conditions that would prevent me from using a special mouth device.You had a sleep study done at the study site's lab in the last 6 months which showed that you have mild to moderate obstructive sleep apnea.You use the O2Vent Optima device for at least 4 hours a night, at least 5 nights a week.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have joined this experiment to date?
"Indeed, clinicaltrials.gov indicates that this study is currently open for enrollment. It was initially published on December 15th 2021 and its parameters were last updated on July 12nd 2023. Twenty patients are needed to be enrolled from a single medical facility."
Answered by AI
Are there any opportunities for participants to sign up for this research endeavor?
"Affirmative, the details posted on clinicaltrials.gov declare that this research project is searching for participants. It was originally listed on December 15th 2021 and most recently updated in July 12th 2023. This trial requires enrolment of 20 people from a single medical site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger