Pressure Relief Algorithm Eval

NCT06407999 | Withdrawn FDA Device

• 1 other identifier: Home 0002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Leak

  Averaged over every night for each 4-night arm

• Usage

  Averaged over every night for each 4-night arm

• AHI

  Averaged over every night for each 4-night arm

Study Arms (2)

APAP w/ EPR On

EXPERIMENTAL

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

APAP w/ EPR Off

PLACEBO COMPARATOR

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

Interventions

Expiratory Pressure Relief DEVICE

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.

Also known as: C-Flex, EPR

APAP w/ EPR Off; APAP w/ EPR On

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SleepRes Inc.: lead

Study Sites (1)

Sleep Centers of Middle Tennessee

Murfreesboro, Tennessee, 37129, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• William H Noah, MD

  SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which are they are in during any point of the study, although since they are adherent (use their device regularly), they likely will be able to tell.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will sleep at home with their normal CPAP (continuous positive airway pressure)/APAP (auto-adjusting...) equipment for 4 nights with EPR (expiratory pressure relief) on, the 4 nights with EPR off. The starting therapy will be randomized.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)