Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F&P Licorice mask in a home environment.
Interventions
DEVICEF&P Licorice Mask
PAP/NIV Therapy 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
* Are ≥22 years of age * Weigh ≥66 pounds * Have been prescribed PAP/NIV therapy by a physician * Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation\* * Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation * Are fluent in spoken and written English * Possess the capacity to provide informed consent
Exclusion criteria
* Are intolerant to PAP/NIV therapy * Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate * Are required to use PAP/NIV therapy for \>12 hours per day or for extensive periods, not including sleep or naps * Are trying to get pregnant, are pregnant, or think they may be pregnant * Have an IPAP pressure of \>30 cmH2O if on BPAP * Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2 * Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site * Have a history of light-induced seizures (for optional anthropometric scan only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Efficacy | Baseline and 14±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 | 14±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) |
| Patient and Clinical Global Impression (PGI/CGI) | Baseline and 14±5 days | Determined by Patient Global Impression (PGI) and Clinical Global Impression (CGI) assessments completed at baseline and Day 14. Baseline symptom severity is assessed using a 6-point scale (1 = No symptoms to 6 = Very severe symptoms). Change from baseline is assessed using a 7-point scale (1 = Very much better to 7 = Very much worse; 4 = No change). Higher severity scores indicate worse symptoms. For change assessments, lower scores indicate improvement and higher scores indicate worsening. PGI is completed by the patient and CGI is completed by the investigator/clinician. |
Countries
United States
Contacts
CONTACTSubbarao Potharaju
Outcome results
None listed