N/A
Completed N=47
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
Obstructive Sleep Apnea · sleep apnea · OSA
Source: ClinicalTrials.gov NCT02387476 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Apnea Hypopnea Index (AHI) — 1.96; 3.73; 1.23; 4.12 events per hour — p=<0.001
Summary
This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
1.96; 3.73; 1.23; 4.12; 2.98; 2.41 | <0.001 sig |
| PRIMARY Oxygen Desaturation Index (ODI) |
1.11; 1.2; 1.05; 1.7; 1.39; 1.12 | <0.001 sig |
| SECONDARY Arousal Index (AI) |
21.95; 20.94; 17.32; 24.00; 22.92; 19.03 | — |
| SECONDARY Sleep Efficiency (SE%) |
80.63; 84.47; 86.68; 78; 79.39; 85.64 | — |
| SECONDARY Minimum Sleep SpO2 (%) |
89.16; 91.41; 91.95; 89.06; 89.11; 91.69 | — |
| SECONDARY Mean Sleep SpO2 -(%) |
94.89; 95.35; 95; 95.41; 95.14; 95.17 | — |
| SECONDARY Wakefulness (Min) |
78.95; 61.06; 51.79; 90.88; 84.58; 56.17 | — |
| SECONDARY Stage N1 (Min) |
43.53; 49.88; 40.26; 53.47 | — |
| SECONDARY Stage N2 (Min) |
193.42; 198.41; 214.89; 188.88 | — |
| SECONDARY Stage N3 (Min) |
59.21; 60.35; 56.21; 42.94 | — |
| SECONDARY REM (Min) |
60.63; 72.29; 93.79; 58.82 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female 18-70 years old;
- Qualifying diagnostic polysomnography (PSG): Resulting in AHI > 5/hr of sleep (using conventional lab or home test);
- Qualifying titration PSG: In lab titration within the past 12 months and therapeutic pressure resulting in Apnea Hypopnea Index (AHI) 1 month;
- Current user of nasal mask or nasal pillow mask;
- Have regular usage of their CPAP machine ( at least 4 hrs per night and at least 5 nights per week) confirmed by secure digital (SD) card download;
- No significant changes in the subject's general health and no change in weight greater than ±10 lbs since titration PSG was performed and CPAP therapy initiated (confirmed from medical records);
- BMI 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee);
- Currently enrolled in any other research study
Data sourced from ClinicalTrials.gov (NCT02387476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.