Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-31
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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PAP System A (with Amalfi) then PAP System B (with CLA11)
Participants will be asked to take home the investigational PAP system (Amalfi) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System A and PAP System B. This arm will first use the Amalfi for 7 days and then use the CLA 11 for 7 days.
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)
Participants will be asked to take home the comparator PAP system B (CLA 11) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System B and PAP System A. This arm will first use the CLA 11 for 7 days and then use the Amalfi 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
130 Years
ALL
Yes
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SLP-23-10-01
Identifier Type: -
Identifier Source: org_study_id
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