Completed

The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea

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What is being tested

Device: Trial nasal mask (F&P)

Device
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

Over 22 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorFisher and Paykel Healthcare
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 5, 2019

Actual date on which the first participant was enrolled.

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited. The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.

Official TitleThe Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Principal SponsorFisher and Paykel Healthcare
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomnias

Criteria

6 inclusion criteria required to participate
Diagnosis of OSA by Physician

≥ 22 years of age

≥ 66 lbs

Prescribed PAP or BPAP therapy for OSA

Show More Criteria

7 exclusion criteria prevent from participating
Inability to give informed consent

Pregnant or think they may be pregnant

PAP Intolerant

Anatomical or Physiological Conditions that make PAP inappropriate

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Clayton Sleep Institute

St Louis, United StatesOpen Clayton Sleep Institute in Google Maps
CompletedOne Study Center