Post Market Clinical Follow Up of ResMed Mask Systems

ResMed

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: New generation CPAP mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT05262439

SLP-21-12-01

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

New generation CPAP mask

Experimental group

Description:

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.

Treatment:

Device: New generation CPAP mask