Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Fisher & Paykel Healthcare CPAP Device
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 22 and over * Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP) * For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.
Exclusion criteria
* Contraindicated for PAP (CPAP or AutoCPAP) therapy * Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea) * Has obesity hypoventilation syndrome or congestive heart failure * Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device * Has implanted electronic medical devices (e.g cardiac pacemakers) * Pregnant or think they may be pregnant * Not fluent in spoken and written English.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational CPAP Device Fisher & Paykel Healthcare CPAP Device
Fisher & Paykel Healthcare CPAP Device: Fisher & Paykel Healthcare CPAP Device | 139 |
| Total | 139 |
Baseline characteristics
| Characteristic | Investigational CPAP Device | — |
|---|---|---|
| Age, Continuous | 55.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 89 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 139 |
| other Total, other adverse events | 0 / 139 |
| serious Total, serious adverse events | 2 / 139 |
Outcome results
Primary
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational CPAP Device | Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. | 1.9 events/hr | Standard Deviation 2.9 |
Primary
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational CPAP Device | Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults | 0 participants |
Primary
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational CPAP Device | Machine Reported Faults, Measured as Number of Patients With Machine Faults | 3 participants |
Primary
Participant Reported Faults, Measured as Number of Participant Complaints
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational CPAP Device | Participant Reported Faults, Measured as Number of Participant Complaints | 9 complaints |
Secondary
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational CPAP Device | How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device | 134 participants |