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TheraPAP Adherence Crossover Study - Trial NCT06413134

Access comprehensive clinical trial information for NCT06413134 through Pure Global AI's free database. This phase not specified trial is sponsored by SleepRes Inc. and is currently Not yet recruiting. The study focuses on Obstructive Sleep Apnea. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT06413134
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TheraPAP Adherence Crossover Study
A Prospective, Randomized, Crossover Study of Therapy Adherence With TheraPAP Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA)

Study Focus

Obstructive Sleep Apnea

TheraPAP

Interventional

device

Sponsor & Location

SleepRes Inc.

Murfreesboro, United States of America

Timeline & Enrollment

N/A

May 10, 2024

Jan 15, 2025

32 participants

Primary Outcome

Usage

Summary

TheraPAP is a novel therapy approach being developed by SleepRes, LLC. for the treatment of
 obstructive sleep apnea (OSA). This algorithm has been integrated into the Sefam S.Box CPAP
 (continuous positive airway pressure) device and both standard CPAP/APAP (auto-titrated PAP)
 as well as TheraPAP can be delivered. TheraPAP is a pressure control algorithm that lowers
 the pressure from the set pressure at the beginning of inspiration and does not return the
 pressure to the full set level until some point in late expiration. In this randomized
 crossover study, the comparative adherence to therapy between TheraPAP and APAP will be
 compared. Each therapy will be used by the patient for six-week periods with randomly
 assigned order, and the usage during each arm will be compared.

ICD-10 Classifications

Sleep apnoea
Sleep disorders
Sleep disorder, unspecified
Primary sleep apnoea of newborn
Nonorganic sleep disorders

Data Source

ClinicalTrials.gov

NCT06413134

Device Trial