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N/A

Toffee Masks for Obstructive Sleep Apnea

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

Study Summary

This trial is testing how well two different masks work for people with sleep apnea who use a machine to help them breathe at night. The masks will be assessed for how well they work, how safe they are, and how comfortable they are.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic Efficacy
Secondary outcome measures
Comfort

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.

Find a Location

Who is running the clinical trial?

Fisher and Paykel HealthcareLead Sponsor
120 Previous Clinical Trials
9,858 Total Patients Enrolled

Media Library

F&P Toffee Nasal and Toffee Nasal Pillows Masks (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05496062 — N/A
Obstructive Sleep Apnea Research Study Groups: F&P Toffee Nasal and Toffee Nasal Pillows Mask
Obstructive Sleep Apnea Clinical Trial 2023: F&P Toffee Nasal and Toffee Nasal Pillows Masks Highlights & Side Effects. Trial Name: NCT05496062 — N/A
F&P Toffee Nasal and Toffee Nasal Pillows Masks (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496062 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any room for new participants in this clinical research?

"At present, no individuals are being sought for this clinical trial. Despite having posted on September 12th 2022 and last updated on August 9th 2022, recruitment is not active at the moment yet 234 other studies still require participants."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Site Partners, LLC - DBA CSP Miami
Clayton Sleep Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
2022. "Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496062.
~35 spots leftby Apr 2025
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