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NCT06413134

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)
SleepRes Inc.·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Obstructive Sleep Apnea
Drug/Device/Intervention
TheraPAP
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
SleepRes Inc.
Location
Murfreesboro, United States of America
Timeline & enrollment
Phase
N/A
Start date
May 10, 2024
End date
Jan 15, 2025
Enrollment
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 apnoeaSleep disordersSleep disorder, unspecifiedPrimary sleep apnoea of newbornNonorganic sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06413134
Type
Device Trial
About this record

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.