Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.
Interventions
DEVICEF&P Caramel
Nasal mask
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
* Persons who are ≥22 years of age * Persons who weigh ≥66 pounds * Persons who have been prescribed PAP therapy by a physician * Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial * Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial * Persons who are fluent in spoken and written English * Persons who possess the capacity to provide informed consent
Exclusion criteria
* Persons who are intolerant to PAP therapy * Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate * Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps * Persons who are trying to get pregnant, are pregnant, or think they may be pregnant * Persons who have an IPAP pressure of \>30 cmH2O if on BPAP * Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen * Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Efficacy | Baseline and14±5 days | Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score. |
| Epworth Sleepiness Scale | Baseline and14±5 days | All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F&P Caramel: Nasal Mask Participants to use nasal mask for 14 days. Caramel Nasal Mask: Nasal mask for the treatment of obstructive sleep apnea (OSA). | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | F&P Caramel: Nasal Mask |
|---|---|
| Age, Customized | 43 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 4 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Epworth Sleepiness Scale
All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes)
Time frame: Baseline and14±5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| F&P Caramel: Nasal Mask | Epworth Sleepiness Scale | 7 Epworth Sleepiness Score (ESS) |
Primary
Therapeutic Efficacy
Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score.
Time frame: Baseline and14±5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| F&P Caramel: Nasal Mask | Therapeutic Efficacy | 1.69 events per hour |