ExVent Accessory for Obstructive Sleep Apnea

Overseen By Sat Sharma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Sleep and Chronobiology, Canada

Must not be taking: Sedatives, Hypnotics

Disqualifiers: Oral infections, Insomnia, Central apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new accessory called ExVent, designed to help people with obstructive sleep apnea (OSA) breathe better during sleep. The ExVent works with the O2Vent Optima device, providing extra support to keep the airway open, similar to other available devices. This trial suits individuals with mild to moderate OSA who regularly use the O2Vent Optima and have had a sleep study confirming their condition in the last six months. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve sleep apnea treatment options.

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 prior data suggests that the ExVent accessory is safe for use in obstructive sleep apnea?

A previous study found that most patients using the ExVent accessory with the O2Vent Optima experienced no major problems, only minor side effects, indicating ease of use. Most participants continued without significant issues, suggesting the treatment is safe for most people. This is encouraging, as the ExVent is based on technology already used for sleep apnea, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ExVent accessory is unique because it offers a new approach to managing obstructive sleep apnea (OSA) that deviates from traditional treatments like CPAP machines and oral appliances. Unlike these standard options, which work by keeping the airway open through mechanical means, ExVent is designed to target the underlying obstruction with a novel mechanism. Researchers are excited about this treatment because it could provide a less intrusive, potentially more comfortable alternative, making it easier for patients to adhere to their therapy and improve their sleep quality.

What evidence suggests that the ExVent accessory is effective for obstructive sleep apnea?

Previous studies found that using the ExVent accessory with the O2Vent Optima significantly improved symptoms of obstructive sleep apnea (OSA) compared to before treatment. The ExVent accessory keeps the airway open during sleep by providing gentle pressure during exhalation. Research has shown that adding ExVent to the O2Vent Optima reduces the number of breathing interruptions during sleep, making it more effective. Most patients using this combination breathed better and did not experience any major problems. This suggests that the ExVent accessory could be a promising option for managing OSA. ^{1 2 6 7 8}

Who Is on the Research Team?

Sat Sharma

Principal Investigator

Centre for Sleep

Are You a Good Fit for This Trial?

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.

I am 22 years old or older.

I can stop using my sleep apnea treatments for up to 7 days.

Exclusion Criteria

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.

You drink more than 3 alcoholic drinks every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Home Use

Subject uses the O2Vent Optima + ExVent for up to 3 months and logs usage hours

12 weeks

PSG Night

Subjects who successfully complete the Home Use Phase will have an in-lab PSG sleep night while using the O2Vent Optima + ExVent

1 night

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ExVent

Trial Overview

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.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

Prospective, open label, single-arm multicenter study

Who Is Running the Clinical Trial?

Centre for Sleep and Chronobiology, Canada

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

A new prosthesis was developed for a 62-year-old edentulous patient to prevent obstructive sleep apnea by positioning the mandible and tongue to reduce airway obstruction during sleep.

The appliance combines mandibular advancement and a vacuum device to hold the tongue forward, providing a novel treatment option for patients who typically have limited solutions for sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnoea in edentulous patients--design of a combination appliance: a case study. Robertson, CJ.[2004]

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

In a pilot study of 14 children aged 8-16 with obstructive sleep apnea syndrome (OSAS), nasal expiratory positive airway pressure (NEPAP) significantly improved the obstructive apnea index compared to a placebo, indicating its potential efficacy as an alternative therapy.

Despite the overall positive results, individual responses to NEPAP varied, with some children showing no improvement or worsening symptoms, highlighting the need for further evaluation of its effectiveness through polysomnography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. Kureshi, SA., Gallagher, PR., McDonough, JM., et al.[2021]

A systematic analysis of adverse events in home mechanical ventilation (HMV) identified key risk factors such as patient transportation, suction, and tracheostomy decannulation, which can jeopardize patient safety.

The study suggests implementing risk mitigation measures, including checklists and reminder functions for caregivers, to enhance safety and prevent errors associated with HMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. Lipprandt, M., Liedtke, W., Langanke, M., et al.[2022]

A new classification monitoring model for adverse events related to medical devices was developed, which helps in systematically assessing and managing risks associated with these devices.

This model aims to enhance the reporting and quality of adverse events, allowing regulatory bodies to focus their supervision efforts more effectively, ultimately improving device safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management]. Ren, W., Zhu, Q., Ding, J., et al.[2018]

In a study involving 67 patients with obstructive sleep apnea (OSA), the use of Provent, an expiratory nasal resistance valve, did not show significant differences in OSA severity compared to a placebo after 2 weeks, indicating it is ineffective for preventing OSA recurrence after CPAP withdrawal.

Both Provent and placebo groups experienced higher OSA severity and blood pressure compared to those continuing CPAP, suggesting that Provent is not a suitable short-term alternative therapy for patients with moderate to severe OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Provent on moderate to severe obstructive sleep apnoea during continuous positive airway pressure therapy withdrawal: a randomised controlled trial. Rossi, VA., Winter, B., Rahman, NM., et al.[2015]

The use of the MedWatcher app, combined with outreach to a Facebook patient community, significantly reduced the time to submit adverse event reports for the Essure device, averaging only 11.4 minutes compared to the typical 40 minutes for traditional methods.

Patients reported a high number of serious adverse events (77.6% of submissions), including hospitalization and permanent damage, and the reports submitted via the app were found to be 15 times more frequent than those through traditional reporting channels, indicating improved engagement and reporting quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bahk, CY., Goshgarian, M., Donahue, K., et al.[2019]

The pilot study involving 30 participants with obstructive sleep apnea (OSA) showed that using a nasal valve device significantly reduced apnea-hypopnea index (AHI) and oxygen desaturation, indicating improved breathing during sleep.

The device also significantly decreased snoring without affecting overall sleep architecture, suggesting it could be a promising new treatment approach for OSA that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. Colrain, IM., Brooks, S., Black, J.[2022]

A significant number of health professionals (62.5% in primary care and 72.5% in hospitals) reported experiencing emotional distress as 'second victims' after adverse events, indicating a widespread impact on their mental well-being.

Feelings of guilt, anxiety, and insecurity were the most common emotional responses among these professionals, highlighting the need for better training and support systems to help them cope with the psychological effects of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The aftermath of adverse events in Spanish primary care and hospital health professionals. Mira, JJ., Carrillo, I., Lorenzo, S., et al.[2022]

In a study of 14 subjects with mild to moderate obstructive sleep apnea (OSA), using a shoulder-head elevation pillow (SHEP) resulted in a mean apnea-hypopnea index (AHI) reduction from 27 to 21, but was less effective than nasal continuous positive airway pressure (nCPAP), which achieved a mean AHI of 5.

While four subjects achieved treatment success with SHEP, nCPAP was successful in 12 subjects, indicating that elevated posture may serve as a second-line therapy for OSA, but it is not as effective as nCPAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevated posture for the management of obstructive sleep apnea. Skinner, MA., Kingshott, RN., Jones, DR., et al.[2018]

Nasal expiratory resistive valves (Provent®) show a linear relationship between pressure and airflow, indicating their potential effectiveness in measuring nasal airflow during sleep, particularly in detecting hypopnoea.

The accuracy of hypopnoea detection using Provent® is significantly influenced by the reference breath chosen for measurement, suggesting that variability in treatment response may be linked to differences in measurement techniques for assessing sleep-disordered breathing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of hypopnoea detection using nasal pressure in the presence of a nasal expiratory resistive device (Provent®). Milne, S., Amis, TC., Wheatley, JR., et al.[2014]

In a study of 58 adults with obstructive sleep apnea (OSA), using a mandibular advancement device (MAD) significantly increased upper airway volume and improved various OSA symptoms over 6 months, with 23 patients achieving a complete response.

Younger patients with a deeper overbite were more likely to respond completely to MAD therapy, suggesting that individual anatomical factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of oral appliance therapy with moderate mandibular advancement on obstructive sleep apnea and upper airway volume. Pahkala, R., Seppä, J., Myllykangas, R., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10591577/

P070 Efficacy of the ExVent Accessory with the O2Vent ...

Treatment with O2Vent Optima and O2Vent Optima + ExVent significantly improved OSA compared to the baseline. Even greater benefit was observed with addition of ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05954026

Use of the ExVent Accessory With the O2Vent Optima Oral ...

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 ...

3.

fortunejournals.com

fortunejournals.com/articles/long-term-complications-and-adverse-effects-associated-with-o2vent-optima-oral-appliance-and-exvent-accessory-in-obstructive-sleep.html

Long term complications and Adverse effects associated ...

Conclusion: Majority of the patients prescribed O2Vent Optima and ExVent accessory were compliant, demonstrated no significant complications and only minor ...

4.

withpower.com

withpower.com/trial/phase-apnea-11-2021-5724f

ExVent Accessory for Obstructive Sleep Apnea

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 ...

5.

openairway.com

openairway.com/anatomy-of-o2vent

Understand how O2Vent works - Open Airway Dental Solutions

ExVent extends the stability of the upper airway, enhancing the efficacy for the treatment of mild to moderate obstructive sleep apnea(OSA). ExVent is ...

6.

academic.oup.com

academic.oup.com/sleep/article/48/Supplement_1/A344/8135263

0795 Novel Oral Appliance Therapy with Positive Expiratory ...

A prospective, open-label study included 17 patients with severe OSA (AHI>30/hr.). Average age: 54.6±5.8 years; mean BMI: 32.6±4.3; 70% were men ...

7.

cdn.fortunejournals.com

cdn.fortunejournals.com/articles/long-term-complications-and-adverse-effects-associated-with-o2vent-optima-oral.pdf

long-term-complications-and-adverse-effects-associated- ...

Conclusion: Majority of the patients prescribed O2Vent Optima and ExVent accessory were compliant, demonstrated no significant complications and.

8.

researchgate.net

researchgate.net/publication/371130788_0570_Use_of_the_ExVent_Accessory_with_the_O2Vent_Optima_Oral_Appliance_for_the_Treatment_of_Obstructive_Sleep_Apnea_-_A_Clinical_Trial

0570 Use of the ExVent Accessory with the O2Vent Optima ...

Results We selected 24 cases for analysis. The participants were encouraged to attend workplace-based CRC screening alongside other annual ...