Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology (OSAEPR)
Primary Purpose
Obstructive Sleep Apnea
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
EPR
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Polysomnographic night
Outpatient CPAP use
Arm Description
intermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study.
Application of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study
Outcomes
Primary Outcome Measures
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
Titrated CPAP level
The titrated CPAP level with and without the application of expiratory pressure relief technology
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
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
Secondary Outcome Measures
CPAP mask pressure
The level of the mask pressure with and without the application of the expiratory pressure relief technology, on the beggining of the inspiration
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
CPAP Leakage, with CPAP on fautomatic mode
The leakage measured by the CPAP algorithm device, measured with and without the expiratory pressure relief technology, on the automatic titrated mode
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
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
Full Information
NCT ID
NCT05219591
First Posted
May 14, 2021
Last Updated
February 4, 2022
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05219591
Brief Title
Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
Acronym
OSAEPR
Official Title
Comparison of the Efficacy of Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). We 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. We 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 patients 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.
Detailed Description
Patients 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, patients will be assessed using questionnaires to assess excessive daytime sleepiness (Epworth Sleepiness Scale) and sleep quality (Pittsburgh Sleep Quality Index).
We will perform physical examination with measurement of cervical and abdominal circumference, measurement of height, weight and blood pressure. We 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 Rspironics), 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 you 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study will be carried out in 4 steps:
During Polysomnography exam: Intermittent application of expiratory pressure relief (EPR), when the peak inspiratory flow will be measured with and without the application of EPR, on sleep stage called N2
During Polysomnography exam: After the intermittent application of EPR, manual CPAP pressure titration will be performed with (CPAP-EPRon) and without EPR on (CPAP-EPRoff), under random order and a blinded observer.
Use of outpatient CPAP, in random order, for a total of 3 weeks:
i. adjusted to the previously titrated pressure CPAP-EPRoff, without the addition of EPR technology (1 week) and with the addition of EPR technology(1 week).
ii. adjusted to the previously titrated pressure CPAP-EPRon, with the addition of EPR technology, for 1 week.
Use of outpatient CPAP, in random order, for a total of 2 weeks:
i. adjusted in automatic mode with adding EPR technology on (1 week) and off (1 week).
Masking
ParticipantInvestigator
Masking Description
Participant Masking: on steps 2, 3 and 4 Investigator Masking: on step 2
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polysomnographic night
Arm Type
Other
Arm Description
intermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study.
Arm Title
Outpatient CPAP use
Arm Type
Other
Arm Description
Application of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study
Intervention Type
Device
Intervention Name(s)
EPR
Intervention Description
application of EPR technology during CPAP treatment
Primary Outcome Measure Information:
Title
Peak Inspiratory Flow
Description
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
Time Frame
1 day
Title
Titrated CPAP level
Description
The titrated CPAP level with and without the application of expiratory pressure relief technology
Time Frame
1 day
Title
Apnea and Hypopnea Index with CPAP on fixed mode
Description
The index of apnea and hypopnea measured with and without the expiratory pressure relief, measured with the titrated CPAP level, on fixed mode
Time Frame
15 days, 5 days each group
Title
Apnea and Hypopnea Index with CPAP on automatic mode
Description
The index of apnea and hypopnea measured with and without the expiratory pressure relief, with the titrated CPAP level, on automatic mode
Time Frame
14 days, 7 days each group
Secondary Outcome Measure Information:
Title
CPAP mask pressure
Description
The level of the mask pressure with and without the application of the expiratory pressure relief technology, on the beggining of the inspiration
Time Frame
1 day
Title
CPAP Leakage, with CPAP on fixed mode
Description
The leakage measured by the CPAP algorithm device, measured with and without the expiratory pressure relief technology, on the fixed titrated mode
Time Frame
15 days, 5 days each group
Title
CPAP Leakage, with CPAP on fautomatic mode
Description
The leakage measured by the CPAP algorithm device, measured with and without the expiratory pressure relief technology, on the automatic titrated mode
Time Frame
14 days, 7 days each group
Title
CPAP usage, with CPAP on fixed mode
Description
The amount of usage, per day, of the CPAP device, titrated on fixed mode, with and without the expiratory pressure relief technology
Time Frame
15 days, 5 days each group
Title
CPAP usage, with CPAP on automatic mode
Description
The amount of usage, per day, of the CPAP device, titrated on automatic mode, with and without the expiratory pressure relief technology
Time Frame
15 days, 5 days each group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
55
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
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