Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
This is an open label, prospective, randomized cross over (or single arm) study for ongoing product 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 phases, 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 who met the inclusion/exclusion criteria will be contacted. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP System A (with Amalfi) then PAP System B (with CLA11) | Experimental | 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 B (with CLA11) then PAP System A (with Amalfi) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAP System A (with Amalfi) then PAP System B (with CLA11) | Device | PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| (usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6 | Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or Criterion Score of 6 Subjective usability scores will be collected from participants on each usability item (e.g., comfort, seal, ease of use). Scores will be collected using an 11-point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable | 6 weeks |
| (efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data | Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or clinically relevant data Objective data stored in the CPAP device will be downloaded wirelessly using a computer program (AirView or ResScan, ResMed). An Apnea hypopnea index (AHI) automatically analyzed by the program will be used. Typically, an AHI <5 demonstrates efficacious treatment. | 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Additional criteria for remote studies:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueling Zhu Manager - Clinical Data and Operations | Contact | +61288842367 | xueling.zhu@resmed.com.au |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
his is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices.
Not provided
Not provided
Not provided
| PAP System B (with CLA11) then PAP System A (with Amalfi) | Device | PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |