Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be on a stable dose of any medications that may affect sleep or PSG, like sedatives or hypnotics.
What data supports the idea that ExVent Accessory for Obstructive Sleep Apnea is an effective treatment?
The available research shows that the ExVent Accessory, which is a nasal valve device, was tested in a pilot study and found to improve breathing during sleep for people with obstructive sleep apnea. This suggests it could be an effective treatment option. However, the study was a pilot, meaning it was small and preliminary, so more research is needed to confirm these results. Compared to other treatments like oral appliances and elevated posture, which also aim to improve airway function, the ExVent Accessory offers a different approach by using expiratory resistance to aid breathing.12345
What safety data exists for the ExVent treatment?
Is the ExVent Accessory a promising treatment for obstructive sleep apnea?
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- ExVent (Procedure)