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NCT06407999

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)
SleepRes Inc.·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Obstructive Sleep Apnea
Drug/Device/Intervention
Expiratory Pressure Relief
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 15, 2024
End date
Sep 30, 2024
Enrollment
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 apnoeaSleep disordersSleep disorder, unspecifiedPrimary sleep apnoea of newbornNonorganic sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06407999
Type
Device Trial
About this record

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.