Pressure Relief Algorithm Eval

Withdrawn before enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT06407999

Run by

SleepRes Inc.

People needed

0

Starts

2025-01-01

Expected to finish

2026-01-01

Last updated by the study team

2024-11-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adherent use of ≥ four hours/night over previous 2 months.
• P95 ≥ 8 cmH2O.

You may not qualify if…

• Excessive alcohol consumption (>14 drinks/week).
• The use of any illegal drug(s).
• Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.

Where it is running

• Sleep Centers of Middle Tennessee — Murfreesboro, Tennessee, United States

Full record on ClinicalTrials.gov

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