Fisher & Paykel Healthcare
Auckland, 0600, New Zealand
NCT Number: NCT02804919
Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
Phase 2: To evaluate the CPAP device with communication functionality with data upload.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Auckland, 0600, New Zealand
Phase 1:Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.
Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fisher & Paykel Healthcare CPAP Device
Time frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Time frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Time frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Time frame: 6 months
Obtained from the follow up visits - Phase 1 and Phase 2 of the trial
Time frame: 6 months
Impression of the device during the follow up visits - Phase 1 only
Fisher and Paykel Healthcare
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT06146101
Apnea, Dyssomnias
Chula Vista, California, United States
View Trial DetailsNCT07723417
Apnea, Dyssomnias
Al Mansurah, Dakahlia Governorate, Egypt
View Trial DetailsNCT04950894
Apnea, Apnea+Hypopnea
Birmingham, Alabama, United States
View Trial Details