Continuous Positive Airway PressureNCT06570629
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
A study testing Oronasal CPAP and Nasal CPAP plus Chinstrap in people with Continuous Positive Airway Pressure and Adverse Effect, run by University of Sao Paulo General Hospital at 1 site 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?
- Oronasal CPAP and Nasal CPAP plus Chinstrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- 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 drops of leak over one night of nasal CPAP
- Persistence of excessive leak at the end of Study A.
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 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
About this study
Official title: Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
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 B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive leak at the end of study A. The order of interventions will be randomized. One of the groups will initially use an oronasal mask for 10 days. A washout period of 7 days under nasal CPAP will follow. After washout, subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days. In the other group, the order of interventions will be the opposite.
- Being tested
- Oronasal CPAP, Nasal CPAP plus Chinstrap
- 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.
Oronasal CPAPDevice
In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
Nasal CPAP plus ChinstrapDevice
In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| Oronasal CPAP | Experimental | CPAP with an oronasal mask for 7 days. Receives: Device: Oronasal CPAP |
| Chinstrap | Experimental | CPAP with a nasal mask and a chinstrap for 7 days. Receives: Device: Nasal CPAP plus Chinstrap |
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 (4)
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
Residual apnea-hypopnea index (AHI)
Residual AHI will be compared during both interventions
Measured: 27 days
Functional Outcomes of Sleep Questionnaire (FOSQ 10)
The FOSQ 10 aims to assess the impacts of daytime sleepiness on daily activities. The FOSQ 10 consists of 10 questions comprising 5 items: General productivity, alertness, activity level, social outcomes, and intimate and sexual relationships. Each item generates a score from 1 to 4, and for items with more than one question, the average of the scores is calculated. The overall score is given by multiplying the average of the item scores by 5, obtaining a value from 5 to 20. The higher the score, the better the individual's functional status.
Measured: 27 days
Pittsburgh questionnaire
The Pittsburgh questionnaire assessed sleep quality over the past month. The questionnaire consists of 19 self-reported questions and 5 questions related to the roommate/bed partner that are not included in the overall score. The 19 self-reported questions are divided into 7 components (respectively, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime sleep dysfunction), and each component is scored on a scale of 0 to 3. The scores are then summed to form an overall scale of 0 to 21 points. The higher the score, the worse the sleep quality, and a PSQI greater than 5 indicates poor sleep quality.
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
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06570629
- Sponsor's protocol ID
- avniocpapn2
- 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
- Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06570629
- Acronym / sponsor ID
- avniocpapn2
- Keywords
- CPAP, Excessive leak, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 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 B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive leak at the end of study A. The order of interventions will be randomized. One of the groups will initially use an oronasal mask for 10 days. A washout period of 7 days under nasal CPAP will follow. After washout, subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days. In the other group, the order of interventions will be the opposite.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oronasal CPAP | Experimental | Device: Oronasal CPAPCPAP with an oronasal mask for 7 days. |
| Chinstrap | Experimental | Device: Nasal CPAP plus ChinstrapCPAP with a nasal mask and a chinstrap for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 drops of leak over one night of nasal CPAP
- Persistence of excessive leak at the end of Study A.
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 |
|---|---|---|
| Oronasal CPAPIn this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized. | Device | Oronasal CPAP |
| Nasal CPAP plus ChinstrapIn this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized. | Device | Chinstrap |
Primary outcome
95th CPAP unintentional leak
Time frame: 27 days
The 95th unintentional leak percentile value will be compared during both interventions
4 secondary outcomes
CPAP Side-effects questionnaire
Time frame: 27 days
Residual apnea-hypopnea index (AHI)
Time frame: 27 days
Functional Outcomes of Sleep Questionnaire (FOSQ 10)
Time frame: 27 days
Pittsburgh 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oronasal CPAP and Nasal CPAP plus Chinstrap in people with Continuous Positive Airway Pressure and Adverse Effect, 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: 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 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?
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 (551126625486, 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.