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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational CPAP device | Experimental | Fisher & Paykel Healthcare CPAP Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisher & Paykel Healthcare CPAP Device | Device | Fisher & Paykel Healthcare CPAP Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. | 6 months | |
| Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults | 6 months | |
| Machine Reported Faults, Measured as Number of Patients With Machine Faults | 6 months | |
| Participant Reported Faults, Measured as Number of Participant Complaints | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matt Uhles | Clayton Sleep Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Sleep Clinic | Huntsville | Alabama | 35801 | United States | ||
| Pulmonary Disease Specialists - Central Florida Sleep Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational CPAP Device | Fisher & Paykel Healthcare CPAP Device Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational CPAP Device | Fisher & Paykel Healthcare CPAP Device Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age wasn't provided by one of the participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. | Posted | Mean | Standard Deviation | events/hr | 6 months |
|
|
Adverse events were collected during the study period of each participant (i.e. 6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational CPAP Device | Fisher & Paykel Healthcare CPAP Device Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Community acquired pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Community acquired pneumonia assessed to be unrelated to trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher & Paykel Healthcare | +64 9 574 0123 | 7044 | CPAP.TRIAL@fphcare.co.nz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2016 | Oct 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Kissimmee |
| Florida |
| 34741 |
| United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| Ohio Sleep Medicine and Neurosciences Institute | Dublin | Ohio | 43017 | United States |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Primary | Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults | Posted | Number | participants | 6 months |
|
|
|
| Primary | Machine Reported Faults, Measured as Number of Patients With Machine Faults | Posted | Number | participants | 6 months |
|
|
|
| Primary | Participant Reported Faults, Measured as Number of Participant Complaints | Posted | Number | complaints | 6 months |
|
|
|
| Secondary | How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device | Posted | Number | participants | 6 months |
|
|
|
| 1 |
| 139 |
| 2 |
| 139 |
| 0 |
| 139 |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | Atrial Fibrillation assessed to be unrelated to trial |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |