NCT06238362

TheraPAP Equivalence Crossover Study

Randomized Crossover Study to Compare Effectiveness of a Device Providing Pressure Drops During Inspiration (TPAP) to Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea (OSA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: SleepRes Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The TheraEquivalence Study is a randomized, controlled, crossover study in participants with OSA. A split-night polysomnogram (PSG) will be conducted on CPAP and TPAP (3.5 h each treatment arm) in previously diagnosed OSA patients, to test the effectiveness of TPAP vs. CPAP. The sequence of periods for each participant are assigned in random order. Therapeutic CPAP level will be defined based on each individual's pressure levels from their currently used APAP device deemed to eliminate breathing obstructions for at least 90/95% of the sleep period (P90/P95) + 1 cmH2O (cm of water pressure). P90/P95 will be defined based on the previous 2 months of adherent Auto-adjusted Positive Airway Pressure (APAP) usage (defined as averaging \> 5 hrs/night). On TPAP Tthe pressure drop during inspiration is generally done in two steps and varies, as outlined in table 1, based on the set pressure level, with larger drops occurring when the set pressure is higher. However, the pressure never goes below 5 cm H20. This lower pressure is returned to the set pressure level about halfway through expiration. These pressure drops are designed to make TPAP considerably more comfortable than CPAP.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
OTHER	TPAP	Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP
DEVICE	CPAP	Gold standard for treating sleep apnea.

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2024-02-02
• Last updated: 2024-11-29
• Results posted: 2024-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study