Save

Post Market Clinical Follow Up of ResMed Mask Systems

RECRUITING

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.

Simpliy with AI

Study details:

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-05-26

Primary completion: 2027-06-01

Study completion finish: 2027-06-01

Study type

TREATMENT

Phase

Trial ID

NCT05262439

Intervention or treatment

DEVICE: New generation CPAP mask

Conditions

• Obstructive Sleep Apnea

Image related to Obstructive Sleep Apnea

Condition: Obstructive Sleep Apnea
DEVICE: New generation CPAP mask
Sydney, New South Wales, Australia
Sponsor: ResMed

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Medical Affairs ResMed

Research sites nearby

Select from list below to view details:

Medical Affairs ResMed
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	DEVICE: New generation CPAP mask All participants entered into the study will be couriered a new generation ResMed mask system to be used with their own CPAP machine and in place of their own mask.

What is the study measuring?

Primary outcome

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
General Usability	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.	up to 90 days

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Post Market Clinical Follow Up of ResMed Mask Systems