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TheraPAP Equivalence Crossover Study

NCT06238362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-29

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • SleepRes Inc.

    lead INDUSTRY

Principal Investigators

  • Abinash Joshi, MD · SleepRes Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-07-08
Completion
2024-07-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06238362 on ClinicalTrials.gov