Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology (OSAEPR)

Comparison of the Efficacy of Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology

Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). The investigators hypothesized that the use of CPAP with EPR is less effective in controlling OSA when compared to CPAP without EPR, applied at the same treatment pressure. The investigators also hypothesized that the CPAP pressure necessary to abolish respiratory events during both manual and automatic CPAP titration with EPR will be greater than the pressure titrated with CPAP without EPR. OSA participants will undergo full polysomnography during CPAP and EPR will be turned on and off in order to test the impact of EPR on airflow and residual AHI.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: EPR

Detailed Description

Participants will be recruited at the sleep clinic. The study will be carried out in 4 steps, the first 2 during one night of full polysomnography (PSG) and the last 2 during CPAP treatment for 4 weeks at home:

1) PSG part 1: Intermittent application of expiratory pressure relief (EPR) during inspiratory flow limitation. Peak inspiratory flow will be measured with and without turning EPR technology on. 2) PSG part 2: After the intermittent application of EPR, polysomnography with manual CPAP titration will be performed with EPR technology on (CPAP-EPRon) and without EPR (CPAP-EPRoff), under random order and one blinded observer.

3) CPAP: Use of outpatient CPAP, in random order, for a total of 3 weeks: i. adjusted to CPAP-EPRoff, without turning EPR on (1 week) and turning EPR on(1 week).

ii. adjusted to CPAP-EPRon, turning EPR on, for 1 week. 4) Use of outpatient CPAP, in random order, for a total of 2 weeks: i. adjusted in automatic mode without turning EPR on (1 week) and turning EPR on (1 week).

Before the start of step 1, participants will be assessed using questionnaires to assess excessive daytime sleepiness (Epworth Sleepiness Scale) and sleep quality (Pittsburgh Sleep Quality Index).

The investigators will perform physical examination with measurement of cervical and abdominal circumference, measurement of height, weight and blood pressure. The investigators will inspect the oropharynx and classify according to the modified Mallampati scale.

In steps 1 and 2 of the study, a CPAP device (model AirSense 10 AutoSet, ResMed Ltd.) will be used coupled to an adapted nasal mask (model ConfortGel Blue Nasal, Philips Respironics), with a sealed hole, which allows the passage of one pharyngeal intraluminal pressure catheter (Millar, Houston, TX, USA). In addition, a heated pneumotachograph (model 3700A, Hans Rudolf, Kansas City, MO) will be attached to the mask.

In steps 3 and 4 of the study, a CPAP device (model AirSense 10 AutoSet, ResMed Ltd.) will be used coupled to a nasal mask (model ConfortGel Blue Nasal, Philips Respironics). This equipment has a technology that allows to change the device settings remotely.

In all steps of the study, the expiratory pressure relief - EPR will be adjusted to level 3, corresponding to 3 cmH2O.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 55
    • Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• both sexes
• aged eighteen or over
• already have baseline polysomnography showing a severe Apnea-Hypopnea Index (AIH), defined according to the current criteria of the American Academy of Sleep Medicine (AASM) as 30 events / hour of sleep or more
• already be using a continuous positive pressure device (CPAP) at a pressure equal to or greater than 9 cmH2O with good adherence, defined as an average use equal to or greater than 4 hours per day.

Exclusion Criteria:

Patients with:

• severe or decompensated respiratory or cardiac diseases
• previous pharyngeal surgery or other sleep disorders, such as parasomnias, narcolepsy or primary insomnia
• users of sedative medications such as opioids, benzodiazepines and muscle relaxants
• uncontrolled diabetes or hyperthyroidism

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Polysomnographic night; intermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study.	Device: EPR; application of EPR technology during CPAP treatment
Other: Outpatient CPAP use; Application of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study	Device: EPR; application of EPR technology during CPAP treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Inspiratory Flow	The value of the peak inspiratory flow, measured before and after the activation of expiratory pressure relief technology, on a flow limitation period of sleep	1 day
Titrated CPAP level	The titrated CPAP level with and without the application of expiratory pressure relief technology	1 day
Apnea and Hypopnea Index with CPAP on fixed mode	The index of apnea and hypopnea measured with and without the expiratory pressure relief, measured with the titrated CPAP level, on fixed mode	15 days, 5 days each group
Apnea and Hypopnea Index with CPAP on automatic mode	The index of apnea and hypopnea measured with and without the expiratory pressure relief, with the titrated CPAP level, on automatic mode	14 days, 7 days each group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP Leakage, with CPAP on fixed mode	The leakage measured by the CPAP algorithm device, measured with and without the expiratory pressure relief technology, on the fixed titrated mode	15 days, 5 days each group
CPAP usage, with CPAP on fixed mode	The amount of usage, per day, of the CPAP device, titrated on fixed mode, with and without the expiratory pressure relief technology	15 days, 5 days each group
CPAP usage, with CPAP on automatic mode	The amount of usage, per day, of the CPAP device, titrated on automatic mode, with and without the expiratory pressure relief technology	15 days, 5 days each group
CPAP mask pressure	The level of the mask pressure with and without the application of the expiratory pressure relief technology, on the beginning of the inspiration	1 day
CPAP Leakage, with CPAP on automatic mode	The leakage measured by the CPAP algorithm device, measured with and without the expiratory pressure relief technology, on the automatic titrated mode	14 days, 7 days each group

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

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

Drug and device information, study documents

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