Post Market Clinical Follow Up of ResMed Mask Systems

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: New generation CPAP mask

• Registration Number: NCT05262439
• Lead Sponsor: ResMed

Brief Summary

Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

Detailed Description

This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-20
• Study First Posted: 2022-03-02
• Study Start: 2022-05-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Participants willing to give written informed consent
• Participants who can read and comprehend English
• Participants who ≥ 18 years of age
• Participants being treated for OSA for ≥ 6 months
• Participants currently using a suitable mask system
• Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards

Exclusion Criteria

• Participants using Bilevel flow generators
• Participants who are or may be pregnant
• Participants with a pre-existing 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.
• Participants believed to be unsuitable for inclusion by the researcher
• Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New generation CPAP mask	New generation CPAP mask	The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released.

Primary Outcome Measures

Name	Time	Method
CPAP Pressure (cmH2O)	up to 90 days	Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Leak (L/minute)	up to 90 days	Calculated leak from CPAP machine which assess how well mask seals on patients
Apnea Hypopnea Index (event/hour)	up to 90 days	Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Adverse Events	up to 90 days	Device related adverse events during the study period will also be assessed.
Usage Hours (hours/night)	up to 90 days	Average usage hours taken from the participant's CPAP device used during the study

Secondary Outcome Measures

Name	Time	Method
General Usability	up to 90 days	Subjective usability scores from participants. Each usability item of the new mask system will be rated on a Likert Scale questionnaire. A score of 10 is considered very favourable whereas score of 0 is considered very unfavourable.

Trial Locations

Locations (1)

Medical Affairs ResMed; 🇦🇺 Sydney, New South Wales, Australia