Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05255744
• Other study ID #: SLP-21-11-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 28, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2023
• Source: ResMed
• Contact: Noelle Leong
• Phone: +6565727198
• Email: Noelle.Leong[@]resmed.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 . 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	Singapore General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	CPAP Pressure (cmH2O)	Calculated average pressure from the CPAP device, which indicates how much pressure patients need to keep the airway open.	6 weeks
Secondary	Usage Hours (hours/night)	Average usage hours taken from the participants' CPAP device used during the study.	6 weeks