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TheraPAP Equivalence Crossover Study
NA trial testing TPAP in Obstructive Sleep Apnea in 50 participants. Completed in 8 July 2024.
| Lead sponsor | SleepRes Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 7 March 2024 |
| Primary completion | 8 July 2024 |
| Estimated completion | 8 July 2024 |
| Sites | 1 location across United States |
SleepRes Inc.
Adults 18 to 70, any sex, with Obstructive 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.
Gold standard measure of CPAP therapy efficacy. Scored as number of respiratory events per hour of sleep. The device is considered efficacious with an apnea-hypopnea index \< 5 events/h.
| Group | Value | 95% CI |
|---|---|---|
| TPAP - Experimental Therapy | 2.9 | ± 4.1 |
| CPAP - Traditional OSA Therapy | 3.2 | ± 3.9 |
Scored as number of respiratory events per hour of sleep spent in rapid eye movement stage. The device is generally considered efficacious with an apnea-hypopnea index in REM \< 5 events/h, however it has to be noted that obstructive sleep apnea during REM sleep is more difficult to treat.
| Group | Value | 95% CI |
|---|---|---|
| TPAP - Experimental Therapy | 4.3 | ± 5.1 |
| CPAP - Traditional OSA Therapy | 6 | ± 6.8 |
Assessment of AHI (apnea hypopnea index) during supine sleep. The device is generally considered efficacious if supine AHI is below 5 events/h, however it has to be noted that obstructive sleep apnea in supine position is more difficult to treat.
| Group | Value | 95% CI |
|---|---|---|
| TPAP - Experimental Therapy | 4.9 | ± 7.5 |
| CPAP - Traditional OSA Therapy | 5.4 | ± 6.9 |
Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak
| Group | Value | 95% CI |
|---|---|---|
| TPAP - Experimental Therapy | 2.8 | ± 3.6 |
| CPAP - Traditional OSA Therapy | 5.1 | ± 4.3 |
Scored as number of respiratory events per hour of sleep spent in non-rapid eye movement stage (NREM). The device is generally considered efficacious with an apnea-hypopnea index in NREM \< 5 events/h.
| Group | Value | 95% CI |
|---|---|---|
| TPAP - Experimental Therapy | 2.3 | ± 4.4 |
| CPAP - Traditional OSA Therapy | 2.2 | ± 3.7 |
Assessment of AHI (apnea hypopnea index) during lateral sleep. The device is generally considered efficacious if lateral AHI is below 5 events/h
| Group | Value | 95% CI |
|---|---|---|
| TPAP - Experimental Therapy | 2.4 | ± 5.4 |
| CPAP - Traditional OSA Therapy | 3 | ± 5.8 |
Time frame: 1 night (half night for each treatment). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | TPAP - Experimental Therapy | CPAP - Traditional OSA The… |
|---|---|---|---|
| Insufficient sleep | Nervous system disorders | — | — |
Data from ClinicalTrials.gov NCT06238362 adverse events section.
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06238362.
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