Obstructive Sleep ApneaOSAEPRNCT05219591
Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
A study testing EPR in people with Obstructive Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- EPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- EPR
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPRDevice
application of EPR technology during CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| Polysomnographic night | Other | intermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study. Receives: Device: EPR |
| Outpatient CPAP use | Other | Application of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study Receives: Device: EPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Titrated CPAP level
The titrated CPAP level with and without the application of expiratory pressure relief technology
Measured: 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
Measured: 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
Measured: 14 days, 7 days each group
Secondary outcomes (5)
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
Measured: 1 day
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
Measured: 15 days, 5 days each group
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
Measured: 14 days, 7 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
Measured: 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
Measured: 15 days, 5 days each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study will be carried out in 4 steps: 1. 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 2. 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. 3. 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. 4. 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219591
- Sponsor's protocol ID
- expiratoryrelief
- Acronym
- OSAEPR
- Status last verified
- Jan 2024
- First submitted
- 14 May 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grad GF, Rosanelli I, Fernandes MD, Monare AB, Yanagimori M, Fragoso da Silva Cruz I, Mariano PMMS, Lorenzi-Filho G, Genta PR. Impairment of upper airway patency and CPAP effectiveness during obstructive sleep apnea treatment with expiratory pressure alleviation: a randomized study. Chest. 2026 Sep 3:S0012-3692(26)06541-4. doi: 10.1016/j.chest.2026.08.041. Online ahead of print.
PubMed 42692288
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
- ClinicalTrials.gov ID
- NCT05219591
- Acronym / sponsor ID
- OSAEPR / expiratoryrelief
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will be carried out in 4 steps: 1. 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 2. 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. 3. 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. 4. 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).
| Arm | Type | Receives |
|---|---|---|
| Polysomnographic night | Other | Device: EPRintermittent application of the EPR technology on CPAP device during step 2, on polysomnographic night of the study. |
| Outpatient CPAP use | Other | Device: EPRApplication of EPR technology during outpatient CPAP usage, on steps 3 and 4 of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPRapplication of EPR technology during CPAP treatment | Device | Outpatient CPAP use, Polysomnographic night |
Primary outcome
Peak Inspiratory Flow
Time frame: 1 day
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
Time frame: 1 day
The titrated CPAP level with and without the application of expiratory pressure relief technology
Apnea and Hypopnea Index with CPAP on fixed mode
Time frame: 15 days, 5 days each group
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
Time frame: 14 days, 7 days each group
The index of apnea and hypopnea measured with and without the expiratory pressure relief, with the titrated CPAP level, on automatic mode
5 secondary outcomes
CPAP mask pressure
Time frame: 1 day
CPAP Leakage, with CPAP on fixed mode
Time frame: 15 days, 5 days each group
CPAP Leakage, with CPAP on automatic mode
Time frame: 14 days, 7 days each group
CPAP usage, with CPAP on fixed mode
Time frame: 15 days, 5 days each group
CPAP usage, with CPAP on automatic mode
Time frame: 15 days, 5 days each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 42692288Grad GF, Rosanelli I, Fernandes MD, Monare AB, Yanagimori M, Fragoso da Silva Cruz I, Mariano PMMS, Lorenzi-Filho G, Genta PR. Impairment of upper airway patency and CPAP effectiveness during obstructive sleep apnea treatment with expiratory pressure alleviation: a randomized study. Chest. 2026 Sep 3:S0012-3692(26)06541-4. doi: 10.1016/j.chest.2026.08.041. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPR in people with Obstructive Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Inspiratory Flow (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.