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Pressure Relief Algorithm Eval - Trial NCT06407999

Access comprehensive clinical trial information for NCT06407999 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 50 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 NCT06407999
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Pressure Relief Algorithm Eval
A Prospective, Randomized, Crossover Study on the Effect of Pressure Relief Algorithms (PRA) on Therapy Pressure in APAP Therapy for Obstructive Sleep Apnea (OSA)

Study Focus

Obstructive Sleep Apnea

Expiratory Pressure Relief

Interventional

device

Sponsor & Location

SleepRes Inc.

Murfreesboro, United States of America

Timeline & Enrollment

N/A

May 15, 2024

Sep 30, 2024

50 participants

Primary Outcome

P95/P90

Summary

The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in
 PAP-adherent participants with OSA. Pre-screening is conducted to establish potential
 eligibility based on regular usage of 4 hours/night on patients who use an APAP device with
 a PRA mode. Participants would then be recruited as described below. For those who sign an
 informed consent, they will be instructed to use the device for the next 8 days with the PRA
 turned on for four consecutive nights and off for four consecutive nights, but in random
 orientation. To make sure that the device is not limited to APAP range when adjusting to
 respond to PRA, the upper limit will be changed to 20 cmH2O during the study. Additionally,
 only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the
 maximum PRA setting of 3 cmH2O can be used.

ICD-10 Classifications

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

Data Source

ClinicalTrials.gov

NCT06407999

Device Trial