Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol

Assessment of the Seal, Comfort, Usability and Performance of the Prototype Whitsundays Nasal Mask System in the Singapore Home Environment

Each Whitsunday mask or AirFit N30i Quiet mask is worn for 7 nights. The overall purpose of this study is to evaluate the performance of the Whitsundays nasal mask system (a prototype mask) compared to the ResMed AirFit N30i Quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Positive Airway Pressure (PAP) Therapy

Detailed Description

This is a randomized, open label, cross over study to evaluate the Whitsundays nasal mask system (prototype mask) against a released mask system, the ResMed AirFit N30i Quiet mask system.

The Whitsundays nasal mask system will be compared with a released mask, ResMed's AirFit N30i Quiet, as it is also a nasal mask and the most appropriate benchmark. Study participants are experienced with CPAP masks and devices and therefore will use their experience to identify areas for potential improvement.

Recruitment will be done via phone calls/ SMS messages/ emails <TBC with PI>. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the mask systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the mask systems. If the participant and assessor are happy to proceed, the participants will use the mask and loan CPAP for trial.

Visit 2: After trialing the mask systems, participants will be asked to complete a questionnaire regarding the seal and comfort of the mask system(s). Participants will then take the second mask system home to test.

Visit 3: The participant will return the masks and CPAP device to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noelle Leong; Phone Number: +6565727198; Email: Noelle.Leong@resmed.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients willing to give written informed consent
• Patients who can read and comprehend English
• Patients who ≥ 21 years of age
• Patients being treated for OSA with PAP therapy for ≥ 6 months
• Patients currently using a suitable mask system (any nasal mask )
• Patients who can trial the masks for up to 7 nights each

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.
• Patients believed to be unsuitable for inclusion by the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whitsundays nasal mask; Participants will be asked to take home the investigational mask to use at night while they sleep in place of their own mask. The participant's therapy and comfort settings will not be altered.	Device: Positive Airway Pressure (PAP) Therapy; PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
Active Comparator: AirFit N30i Quiet mask; Participants will be asked to take home the comparator mask to use at night while they sleep in place of their own mask. The participant's therapy and comfort settings will not be altered.	Device: Positive Airway Pressure (PAP) Therapy; PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective usability	Comparison of the seal, comfort, usability and overall preference of the Whitsundays nasal mask system to the AirFit N30i Quiet mask system and/or Criterion Score of 6	6 weeks
Apnea Hypopnea Index (Events/hour)	Objective AHI taken from the participant's CPAP device used during the trial, with a comparison of the Whitsundays nasal mask to the benchmark AirFit N30i Quiet mask or clinically relevant data. nasal mask system to the AirFit N30i Quiet mask system and/or Criterion Score of 6	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Usability	General subjective usability scores from participant. Each usability items of the Whitsundays Nasal Mask System and AirFit N30i Quiet Mask System will be rated on a Likert Scare questionnaire. A score of 10 is considered very favourable whereas score of 0 is considered very unfavourable.	6 weeks
Leak (L/minute)	Calculated leak from the CPAP device provides information on how well the Whitsundays Nasal Mask and AirFit N30i Quiet Mask fit on the patient.	6 weeks
CPAP Pressure (cmH2O)	Calculated average pressure from the CPAP device, which indicates how much pressure patients need to keep the airway open.	6 weeks
Usage Hours (hours/night)	Average usage hours taken from the participants' CPAP device used during the study.	6 weeks

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 28, 2024
• Primary Completion (Estimated): May 6, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: SLP-21-11-01

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: No
• product manufactured in and exported from the U.S.: No