Post Market Clinical Follow up of ResMed Mask Systems

Obstructive Sleep Apnea Clinical Trial

Official title:

Post Market Clinical Follow up of ResMed Mask Systems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262439
• Other study ID #: SLP-21-12-01
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: June 2027

Study information

• Verified date: December 2022
• Source: ResMed
• Contact: Xueling Zhu, BHSc (Nursing), RN
• Phone: 02 8884 2265
• Email: Xueling.Zhu[@]resmed.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Australia	Medical Affairs ResMed	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Usage Hours (hours/night)	Average usage hours taken from the participant's CPAP device used during the study	up to 90 days
Primary	Leak (L/minute)	Calculated leak from CPAP machine which assess how well mask seals on patients	up to 90 days
Primary	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
Primary	Adverse Events	Device related adverse events during the study period will also be assessed.	up to 90 days
Secondary	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