Continuous Positive Airway PressureNCT06570616
Addressing Unintentional Leakage When Using Nasal CPAP - Study A
A study testing CPAP (fixed mode) and APAP (automatic mode) in people with Continuous Positive Airway Pressure and Adverse Effect, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Continuous Positive Airway Pressure, Adverse Effect, Obstructive Sleep Apnea
- What is being tested?
- CPAP (fixed mode) and APAP (automatic mode)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of moderate and severe obstructive sleep apnea;
- Use of CPAP with a nasal mask;
- 95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events
Who cannot join
- Patients who experience unintentional leakage from the mask/accessories.
- Diagnostic polysomnography examination with a predominance of central apnea;
- Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD;
- Previous surgery for obstructive sleep apnea;
- Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, 55
Pedro R Genta, MD, 551126625486, prgenta@usp.br
Ivana Rosanelli, 11950782221, ivanarosanelli2107@gmail.com
- Recruiting
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 03134-002
PEDRO R GENTA, +55 11 99343-7027, prgenta@gmail.com
IVANA ROSANELLI, +55 11 950782221, ivanarosanelli2107@gmail.com
About this study
Official title: Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure
Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.
Read the detailed description
Study A will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed CPAP, starting at the 90 th percentile obtained during a period of auto-CPAP. The order of interventions will be randomized. Auto-CPAP with a nasal mask will be used for 7 days. In the fixed CPAP arm, CPAP will be progressively reduced over a period of up to 21 days until leak is controlled or residual apnea-hypopnea index increases over 10 events/h. Subjects that persisted with excessive leak at the end of the Study A will be invited to Study B.
- Being tested
- CPAP (fixed mode), APAP (automatic mode)
- Keywords
- CPAP, Excessive leak, Obstructive Sleep Apnea
- 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.
CPAP (fixed mode)Device
Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.
APAP (automatic mode)Device
Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.
| Study group | Role | What they receive |
|---|---|---|
| AutoCPAP | Experimental | Subjects will use auto CPAP during 7 days. Receives: Device: APAP (automatic mode) |
| Fixed | Experimental | Subjects will start with the CPAP level obtained during auto-CPAP titration. CPAP will be decreased according to the study protocol. Receives: Device: CPAP (fixed mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
95th CPAP unintentional leak
The 95th unintentional leak percentile value will be compared during both interventions
Measured: 27 days
Secondary outcomes (1)
CPAP Side-effects questionnaire
This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale.
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start30 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Positive Airway PressureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Rodrigues Genta, University of Sao Paulo General Hospital
- Investigators
- Pedro Genta, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570616
- Sponsor's protocol ID
- avniocpapn1
- Status last verified
- Apr 2025
- First submitted
- 25 Jan 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT06570616
- Acronym / sponsor ID
- avniocpapn1
- Keywords
- CPAP, Excessive leak, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 2024 (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.
Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.
Detailed description
Study A will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed CPAP, starting at the 90 th percentile obtained during a period of auto-CPAP. The order of interventions will be randomized. Auto-CPAP with a nasal mask will be used for 7 days. In the fixed CPAP arm, CPAP will be progressively reduced over a period of up to 21 days until leak is controlled or residual apnea-hypopnea index increases over 10 events/h. Subjects that persisted with excessive leak at the end of the Study A will be invited to Study B.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| AutoCPAP | Experimental | Device: APAP (automatic mode)Subjects will use auto CPAP during 7 days. |
| Fixed | Experimental | Device: CPAP (fixed mode)Subjects will start with the CPAP level obtained during auto-CPAP titration. CPAP will be decreased according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of moderate and severe obstructive sleep apnea;
- Use of CPAP with a nasal mask;
- 95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events
Key exclusion criteria (5 listed)
- Patients who experience unintentional leakage from the mask/accessories.
- Diagnostic polysomnography examination with a predominance of central apnea;
- Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD;
- Previous surgery for obstructive sleep apnea;
- Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).
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 |
|---|---|---|
| CPAP (fixed mode)Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm. | Device | Fixed |
| APAP (automatic mode)Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm. | Device | AutoCPAP |
Primary outcome
95th CPAP unintentional leak
Time frame: 27 days
The 95th unintentional leak percentile value will be compared during both interventions
1 secondary outcome
CPAP Side-effects questionnaire
Time frame: 27 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Pedro Genta principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP (fixed mode) and APAP (automatic mode) in people with Continuous Positive Airway Pressure and Adverse Effect, run by University of Sao Paulo General Hospital at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Genta (551126615486, prgenta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
95th CPAP unintentional leak (time frame: 27 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.