NCT05262439

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. .

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
May 2022Jun 2027

First Submitted

Initial submission to the registry

February 3, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

February 3, 2022

Last Update Submit

April 23, 2026

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • General Usability

    up to 90 days

Study Arms (1)

New generation CPAP mask

EXPERIMENTAL

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

Interventions

New generation CPAP maskDEVICE

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.

New generation CPAP mask

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Affairs ResMed

Sydney, New South Wales, 2153, Australia

RECRUITING

Related Publications (1)

  • Zhu X, Benjafield A, Deas R, Willes L, Armitstead J. Feasibility and acceptability of switching from a previous-generation to a new-generation mask for positive airway pressure therapy of sleep apnea using remote care. Sleep Med X. 2024 Oct 11;8:100128. doi: 10.1016/j.sleepx.2024.100128. eCollection 2024 Dec 15.

    PMID: 39498349DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jeff Armistead, PhD

    ResMed

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueling Zhu, BHSc (Nursing), RN

CONTACT

02 8884 2265Xueling.Zhu@resmed.com.au

Ross Deas, PhD

CONTACT

02 8884 1703ross.deas@resmed.com.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

March 2, 2022

Study Start

May 26, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

AU(1)