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.123510
Is the ExVent Accessory a promising treatment for obstructive sleep apnea?Yes, the ExVent Accessory, which uses a nasal expiratory resistance device, shows promise as a treatment for obstructive sleep apnea. It helps improve breathing during sleep by using a special valve that makes it easier to breathe out, which can be beneficial for people with sleep apnea.13456
What safety data exists for the ExVent treatment?The provided research does not contain specific safety data for the ExVent treatment or its variants. The articles focus on general adverse event reporting and management for medical devices, but do not mention ExVent, ExVent Accessory, or ExVent Valve specifically.7891112
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
I have completed the initial fitting for the O2Vent Optima device.
Exclusion Criteria
I am a woman who could become pregnant and plan to during the study.
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.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Prospective, open label, single-arm multicenter study
Find a clinic near you
Research locations nearbySelect from list below to view details:
Centre for Sleep and ChronobiologyToronto, Canada
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Who is running the clinical trial?
Centre for Sleep and Chronobiology, CanadaLead Sponsor
References
Treatment of obstructive sleep apnoea in edentulous patients--design of a combination appliance: a case study. [2004]This report describes the fabrication of a prosthesis to prevent obstructive sleep apnoea in edentulous patients. The objective of treatment in a 62-year-old man was to establish a comfortable protrusive and vertical position of the mandible that minimised hypopharyngeal obstruction nocturnally. An appliance was designed incorporating two concepts in the elimination of obstructive sleep apnoea: mandibular advancement, which maintains hypopharyngeal width nocturnally; and advancement of the tongue with the aid of a device holding the tongue in a protrusive position by vacuum pressure. This combination appliance offers a treatment modality to a large group of otherwise forgotten patients.
Elevated posture for the management of obstructive sleep apnea. [2018]This study aimed to evaluate the effectiveness of elevated posture in the management of obstructive sleep apnea (OSA). Fourteen subjects presenting with mild-moderate OSA, (apnea-hypopnea index [AHI] 10 to 60/h), were included in a randomized crossover investigation. A shoulder-head elevation pillow (SHEP) was compared with nasal continuous positive airway pressure (nCPAP) therapy. Treatment success was defined as AHI10
A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. [2022]Obstructive sleep apnea (OSA) is a major problem in need of new treatment approaches. The present pilot study tests the hypothesis that the application of expiratory resistance via a nasal valve device would improve breathing during sleep in subjects with OSA and in primary snorers.
The effects of Provent on moderate to severe obstructive sleep apnoea during continuous positive airway pressure therapy withdrawal: a randomised controlled trial. [2015]The aim of this study was to test the effectiveness of Provent, an expiratory nasal resistance valve, to prevent the recurrence of OSA following CPAP withdrawal.
Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. [2021]Alternative therapies for childhood obstructive sleep apnea syndrome (OSAS) are needed as OSAS may persist despite adenotonsillectomy, and continuous positive airway pressure (CPAP) adherence is low. Nasal expiratory positive airway pressure (NEPAP) devices have not been studied in children. We hypothesized that NEPAP would result in polysomnographic improvement. Further, we aimed to determine NEPAP adherence, effects on sleepiness, behavior, and quality of life.
Sensitivity and specificity of hypopnoea detection using nasal pressure in the presence of a nasal expiratory resistive device (Provent®). [2014]Nasal expiratory resistive valves (Provent(®)) have been proposed as novel therapy for obstructive sleep apnea. We compared pressure measurements from a standard nasal pressure catheter used to assess nasal airflow during sleep with those from nasal expiratory resistive device with attached proprietary nasal pressure cannula. Nasal pressure cannula or Provent(®) + proprietary nasal pressure cannula were attached to a bench model of human anterior nares and nasal passages, and pressure measured (P). Respiratory airflows generated by a subject breathing were applied to rear of model and airflow (V) measured via pneumotachograph. Airflow amplitude (ΔV) was plotted against pressure amplitude (ΔP). Hypopnoea detection ( 0.65, p
The aftermath of adverse events in Spanish primary care and hospital health professionals. [2022]Adverse events (AEs) cause harm in patients and disturbance for the professionals involved in the event (second victims). This study assessed the impact of AEs in primary care (PC) and hospitals in Spain on second victims.
Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. [2019]Label="BACKGROUND" NlmCategory="BACKGROUND">Preparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. In 2012, the FDA Center for Devices and Radiologic Health (CDRH) launched a free, public mobile AE reporting app, MedWatcher, for patients and clinicians. During the same year, a patient community on Facebook adopted the app to submit reports involving a hysteroscopic sterilization device, brand name Essure®.
[Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management]. [2018]To increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.
The impact of oral appliance therapy with moderate mandibular advancement on obstructive sleep apnea and upper airway volume. [2021]To find out if a moderate protrusion with a mandibular advancement device (MAD) can significantly increase the upper airway volume and, further, what signs and symptoms of obstructive sleep apnea (OSA) can be improved by this maneuver.
Post-market surveillance of consumer products: Framework for adverse event management. [2022]Analysis of spontaneous reports of adverse events is an important source of information that can be used to improve consumer products. Various agencies have adverse event reporting requirements and many companies collect such data directly from consumers. Nonetheless, a universal framework is absent that identifies and evaluates spontaneously reported adverse events, and, most important, assesses the potential association between exposure and adverse events. We are presenting a three-part framework: Phase I - Intake and Documentation of Original Incidents; Phase II - In Depth Review and Follow-up of Phase I Incidents (enhanced, tailored questionnaire); Phase III - Association Assessment. The basis for scoring the strength of association between exposure and adverse events requires assessment of standard factors of association including: temporality; biological, physiological, or pharmacological plausibility; results of de-challenge; results of re-challenge; and consideration of confounding factors. Scores tied to the answers to these questions are totaled for each incident to determine the strength of association between exposure and reported adverse event. We propose that consumer product companies come together to adopt such an association assessment framework to improve adverse event management, obtain maximum value from the data obtained, and use the knowledge derived to improve overall product safety for consumers.
Causes of adverse events in home mechanical ventilation: a nursing perspective. [2022]Adverse events (AE) are ubiquitous in home mechanical ventilation (HMV) and can jeopardise patient safety. One particular source of error is human interaction with life-sustaining medical devices, such as the ventilator. The objective is to understand these errors and to be able to take appropriate action. With a systematic analysis of the hazards associated with HMV and their causes, measures can be taken to prevent damage to patient health.