PAP Systems Internal Clinical Studies (ICS)

Obstructive Sleep Apnea Clinical Trial

Official title:

Internal Evaluation of PAP Systems: Comparison of PAP Flow Generators Machines, Mask Systems and Tubing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06173050
• Other study ID #: SLP-23-10-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: ResMed
• Contact: Noelle Leong
• Phone: +6565727198
• Email: Noelle.Leong[@]resmed.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems to guide product development.

Description:

This is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices. This generic protocol provides a framework methodology for how these ongoing studies will be conducted. This protocol then is used in a number of smaller sub-studies, each of which will have their own sub-protocol outlining the exact specifics of the study.

The studies could be run face-to-face or remotely.

Participants are healthy volunteers who are ResMed employees. Recruitment will be done via emails. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the PAP systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the PAP systems. If the participant and assessor are happy to proceed, the participants will use the loan PAP system for trial.

Visit 2: After trialing the PAP systems, participants will be asked to complete a questionnaire regarding the appeal, comfort, and usability of the PAP system(s). Depending on sub-study protocol, participants will then take the second PAP system home to test.

Visit 3: The participant will return the loan PAP system to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Participants who are employees of ResMed

• Participants shall be volunteers

• Participants willing to give written informed consent

• Participants who = 18 years of age

• Participants willing and able to complete the specified tasks

Exclusion Criteria:

• Participants who are or may be pregnant.

• Participants with a preexisting 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 medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• PAP System A (with Amalfi) then PAP System B (with CLA11)
PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days
• PAP System B (with CLA11) then PAP System A (with Amalfi)
PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective outcomes parameters scores	Subjective outcomes parameters scores from participants. Each subjective outcomes item of the investigational component/s of the PAP System will be rated on a Likert Scale questionnaire. Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.	6 weeks