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Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System
NA trial testing positive airway pressure system in Sleep Apnea in 52 participants. Completed in 7 January 2020.
| Lead sponsor | FRESCA Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 14 October 2019 |
| Primary completion | 7 January 2020 |
| Estimated completion | 7 January 2020 |
| Sites | 6 locations across United States |
FRESCA Medical
Adults 22 to 75, any sex, with Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The mean combined number of apnea and hypopnea events per hour of sleep
| Group | Value | 95% CI |
|---|---|---|
| FRESCA Flow Generator | 3.20 | ± 8.620 |
| FRESCA Airbox Flow Generator | 4.86 | ± 10.047 |
The number of oxygen desaturations ≥ 4% per hour of sleep
| Group | Value | 95% CI |
|---|---|---|
| FRESCA Flow Generator | 3.12 | ± 9.274 |
| FRESCA Airbox Flow Generator | 4.69 | ± 10.425 |
Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | FRESCA Flow Generator | FRESCA Airbox Flow Generator |
|---|---|---|---|
| difficulty breathing | General disorders | — | — |
| skin/nose irritation | Skin and subcutaneous tissue disorders | — | — |
| difficulty sleeping | General disorders | — | — |
| discomfort from headgear | General disorders | — | — |
| dreaming of suffocating | Psychiatric disorders | — | — |
| headache | Nervous system disorders | — | — |
| increased effort with inhalation and exhalation | General disorders | — | — |
| intermittent pain to nose | Respiratory, thoracic and mediastinal disorders | — | — |
| sore throat | Respiratory, thoracic and mediastinal disorders | — | — |
Data from ClinicalTrials.gov NCT03999944 adverse events section.
Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing