Post Market Clinical Follow Up of ResMed Mask Systems

Last updated: October 14, 2024
Sponsor: ResMed
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

New generation CPAP mask

Clinical Study ID

NCT05262439
SLP-21-12-01
  • Ages 18-100
  • All Genders

Study 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. .

Eligibility Criteria

Inclusion

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 downloadcapacity from CPAP machine from data cards

Exclusion

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 themto 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 beacceptable) (for masks with magnetic clips only)

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: New generation CPAP mask
Phase:
Study Start date:
May 26, 2022
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Medical Affairs ResMed

    Sydney, New South Wales 2153
    Australia

    Active - Recruiting

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