Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol

NCT05255744 | Terminated DMC

• 1 other identifier: SLP-21-11-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• General Usability

  6 weeks

• Leak (L/minute)

  6 weeks

• CPAP Pressure (cmH2O)

  6 weeks

• Usage Hours (hours/night)

  6 weeks

Study Arms (2)

Whitsundays nasal mask

EXPERIMENTAL

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

AirFit N30i Quiet mask

ACTIVE COMPARATOR

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

Interventions

Positive Airway Pressure (PAP) Therapy DEVICE

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.

AirFit N30i Quiet mask; Whitsundays nasal mask

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ResMed: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Resmed Asia Pacific Pte Ltd

Singapore, Singapore

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: February 24, 2022
• Study Start: March 28, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 31, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)