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Recruiting

NCT Number: NCT05262439

Post Market Clinical Follow up of ResMed Mask Systems

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. .

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Affairs ResMed

Sydney, New South Wales, 2153, Australia

Location status: Recruiting

Location contact

Jeff Armitstead, PhD

CONTACT

61488840000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

New generation CPAP mask

Device

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.

Primary outcomes

  1. Apnea Hypopnea Index (event/hour)

    Time frame: up to 90 days

    Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study

  2. Usage Hours (hours/night)

    Time frame: up to 90 days

    Average usage hours taken from the participant's CPAP device used during the study

  3. Leak (L/minute)

    Time frame: up to 90 days

    Calculated leak from CPAP machine which assess how well mask seals on patients

  4. CPAP Pressure (cmH2O)

    Time frame: up to 90 days

    Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open

  5. Adverse Events

    Time frame: up to 90 days

    Device related adverse events during the study period will also be assessed.

Secondary outcomes

  1. General Usability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ross Deas, PhD

CONTACT

[email protected]

02 8884 1703

Xueling Zhu, BHSc (Nursing), RN

CONTACT

[email protected]

02 8884 2265

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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