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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Expiratory Pressure Relief

Detailed Description

The first phase of recruiting for the PRA Effect on APAP Therapy Pressure Study will be done during a single phone contact following an email recruitment. During this call, participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria. If the participant is eligible to enter the study, they will be sent an electronic Informed Consent Form to sign. Once the form is signed and verified, the study can then start that evening, after the participant's device has been set for the study.

During both arms of the study, every aspect of operation of the APAP devices will be the same as those the patient normally uses, except for the following three things:

• APAP upper range limit will be set to 20 cmH2O
• PRA or 3 cmH2O will be either on or off
• Participants cannot use a V̇-Com™ device. Participants will randomly be assigned to start with or without PRA. Once the settings are remotely assigned to the device, the patient will sleep on these settings for four nights, ideally consecutively.

After four nights, the PRA setting will be remotely switched to the 2nd arm setting (on or off), and median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded. The participant will then use the device with the new settings for an additional four nights, hopefully also sequentially.

Following the 2nd group of four nights, median and P95 pressure, Usage, AHI, and Leak averaged over those four nights will be downloaded, the participant will be informed that their involvement in the study is complete, and the device will be remotely set back to the settings it had prior to the study. Participants will then receive the compensation credit.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • Sleep Centers of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Excessive alcohol consumption (>14 drinks/week).
2. The use of any illegal drug(s).
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APAP w/ EPR On; The patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR on if they do not already use it that way.	Device: Expiratory Pressure Relief; EPR is a function used in CPAP intended to improve comfort by reducing delivered pressure during the expiratory phase. When EPR is not used, the patient receives true CPAP.; Other Names: C-Flex, EPR
Placebo Comparator: APAP w/ EPR Off; The patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR off if they do not already use it that way.	Device: Expiratory Pressure Relief; EPR is a function used in CPAP intended to improve comfort by reducing delivered pressure during the expiratory phase. When EPR is not used, the patient receives true CPAP.; Other Names: C-Flex, EPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P95/P90	P95/P90 represent pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period	Averaged over every night for each 4-night arm

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak	Leak measured by the device in excess of the required exhaust valve leak to purge CO2 from the breathing circuit.	Averaged over every night for each 4-night arm
Usage	Elapsed therapy usage time measured each night	Averaged over every night for each 4-night arm
AHI	Apnea/Hypopnea Index - Measurement of obstructive events averaged over the night in events per hour.	Averaged over every night for each 4-night arm

Collaborators and Investigators

• Sponsor: SleepRes Inc.
• Investigators: Study Director: William H Noah, MD, SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: Home 0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only plan to publish results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes