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: Unknown

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 4 11 12}

Research Team

Sat Sharma

Principal Investigator

Centre for Sleep

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.

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

The impact of oral appliance therapy with moderate mandibular advancement on obstructive sleep apnea and upper airway volume. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

Elevated posture for the management of obstructive sleep apnea. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. [2022]

7. New Zealand 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. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The aftermath of adverse events in Spanish primary care and hospital health professionals. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of hypopnoea detection using nasal pressure in the presence of a nasal expiratory resistive device (Provent®). [2014]

12. England 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. [2015]