What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea, such as continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) therapies, can have side effects including nasal congestion, dry mouth, skin irritation from the mask, and discomfort or difficulty tolerating the pressure. Some patients may also experience aerophagia, leading to bloating and gas. These side effects can often be managed with adjustments to the mask fit, humidification, or pressure settings.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA) that involve the use of continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) devices. These devices, such as the F&P Toffee Nasal and Toffee Nasal Pillows masks, work by delivering a steady stream of air through a mask to keep the airways open during sleep. Additionally, while various pharmacologic agents have been investigated, none have proven sufficiently effective to replace PAP therapy as the primary treatment for OSA. Therefore, CPAP and BiPAP remain the mainstay of FDA-approved treatments for managing OSA.

What other types of research exist?

Promising novel alternatives to the F&P Toffee Nasal and Toffee Nasal Pillows masks for OSA patients include: 1. Nasal pillows with advanced air leak reduction and improved comfort, such as the ResMed AirFit P30i. 2. Full-face masks with enhanced seal and reduced pressure points, like the Philips Respironics DreamWear Full Face Mask. 3. Adaptive servo-ventilation (ASV) devices for patients with complex sleep apnea, such as the ResMed AirCurve 10 ASV. 4. Auto-adjusting PAP (APAP) devices that optimize pressure settings in real-time, like the Fisher & Paykel SleepStyle Auto CPAP. These alternatives offer improved patient comfort, better adherence, and advanced features for effective OSA management.

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N/A

Toffee Masks for Obstructive Sleep Apnea

Q: What is the mechanism of action of this treatment?

The most common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) and Bi-level Positive Airway Pressure (BiPAP) therapies. These treatments work by delivering a steady stream of air through a mask, such as the F&#x26;P Toffee Nasal and Toffee Nasal Pillows masks, to keep the upper airway open during sleep. This prevents the airway from collapsing, which is the primary cause of apneas and hypopneas in OSA patients. By maintaining airway patency, these therapies reduce the frequency of breathing interruptions, improve oxygenation, and enhance sleep quality. This is crucial for OSA patients as it mitigates the risk of complications such as cardiovascular issues, daytime sleepiness, and neuropsychiatric dysfunction.

Q: What other types of research exist?

Promising novel alternatives to the F&#x26;P Toffee Nasal and Toffee Nasal Pillows masks for OSA patients include: 1. Nasal pillows with advanced air leak reduction and improved comfort, such as the ResMed AirFit P30i. 2. Full-face masks with enhanced seal and reduced pressure points, like the Philips Respironics DreamWear Full Face Mask. 3. Adaptive servo-ventilation (ASV) devices for patients with complex sleep apnea, such as the ResMed AirCurve 10 ASV. 4. Auto-adjusting PAP (APAP) devices that optimize pressure settings in real-time, like the Fisher &#x26; Paykel SleepStyle Auto CPAP. These alternatives offer improved patient comfort, better adherence, and advanced features for effective OSA management.

N/A

Waitlist Available

Research Sponsored by Fisher and Paykel Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Persons who are ≥ 22 years of age

Persons who weigh ≥ 66 lbs (30 kgs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after two weeks of use

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new nasal masks for people who use breathing machines at home. The goal is to see if these masks are effective, safe, and comfortable for users.

Who is the study for?

This trial is for adults over 22 years old with Obstructive Sleep Apnea who use PAP therapy nightly, have a prescribed pressure of <20 cmH2O, and are not pregnant. Participants must weigh at least 66 lbs, speak English fluently, be able to give informed consent, and currently use certain types of PAP masks.

What is being tested?

The study evaluates the effectiveness, safety, and comfort of two new masks for PAP therapy: F&P Toffee Nasal and Toffee Nasal Pillows Masks. It's conducted in participants' homes to see how well these masks work during regular sleep therapy sessions.

What are the potential side effects?

While specific side effects aren't listed here, typical concerns with new PAP masks may include discomfort on the face or nose, skin irritation or marks from mask fitting, dryness in nasal passages or mouth if poorly fitted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

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I weigh at least 66 pounds (30 kg).

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I have been prescribed a PAP machine for sleep therapy.

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I understand the details of the clinical trial and can agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after two weeks of use

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after two weeks of use

This trial's timeline: 3 weeks for screening, Varies for treatment, and after two weeks of use for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic Efficacy

Secondary study objectives

Comfort

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: F&P Toffee Nasal and Toffee Nasal Pillows MaskExperimental Treatment1 Intervention

Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

F&P Toffee Nasal and Toffee Nasal Pillows Masks

2022

N/A

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) and Bi-level Positive Airway Pressure (BiPAP) therapies. These treatments work by delivering a steady stream of air through a mask, such as the F&P Toffee Nasal and Toffee Nasal Pillows masks, to keep the upper airway open during sleep. This prevents the airway from collapsing, which is the primary cause of apneas and hypopneas in OSA patients. By maintaining airway patency, these therapies reduce the frequency of breathing interruptions, improve oxygenation, and enhance sleep quality. This is crucial for OSA patients as it mitigates the risk of complications such as cardiovascular issues, daytime sleepiness, and neuropsychiatric dysfunction.

Obstructive sleep apnoea syndrome in children.