Whitsundays (Nasal) Mask Take Home Study (90 Days)

February 27, 2024 updated by: ResMed

Evaluating the Usability and Performance of a PAP Mask System in the Home Environment

The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. The main questions it aims to answer are:

  • How the Whitsundays masks performs in the home environment
  • What is the subject's first impression of the Whitsundays mask and what is their preference compared to their own mask
  • What is the difference between the subject's objective therapy data when using the Whitsundays mask compared to their own mask
  • Is there wear and tear of the Whitsundays mask and how frequently do the cushions need replacement Participants will be asked to use the Whitsundays mask for 90 days, answer questionnaires about the initial impression of the mask, the performance of the mask, and their preference compared to their own mask. Researchers will compare one group of subjects who will be provided with cushion replacements to another group who will only be provided with cushion replacements upon request to determine the need for cushion replacement, its frequency, and the reasons for cushion replacement during home usage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Sleep Data
    • Missouri
      • Saint Louis, Missouri, United States, 63123
        • Clayton Sleep Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients willing to give written informed consent
  • Patients who can read and comprehend English
  • Patients who ≥ 18 years of age
  • Patients being treated for OSA with a PAP device for ≥ 6 months
  • Patients currently using a ResMed PAP device (S9, AirSense 10 & AirSense 11) compatible with AirView (with cellular data connectivity and has been sending device data to the cloud)
  • Patients currently using ResMed AirFit N30i or Philips DreamWear™ Nasal
  • Patients who are willing to try the prototype mask for up to 90 nights
  • Patients who are willing to take photos of the prototype mask every 2 weeks for the duration of the study
  • Patients who reside in the USA and intend to stay in the USA for the next 6 months
  • Patients with access to the internet (such as a smartphone or laptop) to complete online surveys

Exclusion Criteria:

  • Patients using Bilevel flow generators
  • Patients who are or may be pregnant
  • Patients with a preexisting lung disease/condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
  • If you are pregnant or planning to become pregnant
  • Patients believed to be unsuitable for inclusion by the researcher

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion
• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)
Device: Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion
Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)
Experimental: Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Device: Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
11 point Likert Scale Questionnaire
Time Frame: 90 days
• Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
11 point Likert Scale Questionnaire
Time Frame: 90 days
• Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
90 days
Apnea Hypopnea Index (AHI)
Time Frame: 90 days
• The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
90 days
Compliance
Time Frame: 90 days
• The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Whitsundays mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
90 days
Leak
Time Frame: 90 days
The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.
90 days
Pressure Differences
Time Frame: 90 days
The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Whitsundays mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
90 days
Frequency of Cushion Replacement
Time Frame: 90 days
• Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
90 days
Reason for Cushion Replacement
Time Frame: 90 days
• Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
90 days
Deterioration of Mask
Time Frame: 90 days
• Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: William Hevener, RPSGT, Sleep Data
  • Principal Investigator: Matthew Uhles, MS, Clayton Sleep Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Actual)

November 6, 2023

Study Completion (Actual)

November 6, 2023

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLP-23-02-01
  • D638-1118 (Other Identifier: ResMed)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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