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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
Must not have
Female of child-bearing age who is pregnant or intending to become pregnant during the study participation period
Any concomitant diagnosed or suspected sleep disorder including insomnia or central apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have completed the initial fitting for the O2Vent Optima device.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman who could become pregnant and plan to during the study.
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I have or might have a sleep disorder like insomnia or central apnea.
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I have had surgery for sleep apnea, including RF ablation or used a palatal stent.
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I don't have any oral infections or conditions that would prevent me from using a special mouth device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in AHI between baseline AHI and the AHI measured during the in-lab PSG sleep night using the O2Vent Optima + ExVent.
Secondary study objectives
Adverse events will be summarized descriptively in terms of type and frequency

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Single arm Clinical Trial Eligibility Overview. Trial Name: NCT05954026 — N/A
Sleep Apnea Research Study Groups: Single arm
Sleep Apnea Clinical Trial 2023: Single arm Highlights & Side Effects. Trial Name: NCT05954026 — N/A
Single arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05954026 — N/A
~0 spots leftby Dec 2024
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