Comparing oronasal and nasal CPAP with chinstrap for sleep apnea
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
NA · University of Sao Paulo General Hospital · NCT06570629
This study is testing whether using an oronasal mask or a nasal mask with a chinstrap helps people with sleep apnea reduce unwanted air leaks during CPAP treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital (other) |
| Locations | 1 site (São Paulo, Brazil) |
| Trial ID | NCT06570629 on ClinicalTrials.gov |
What this trial studies
This study aims to address the common issue of unintentional leakage during continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). It will compare the effectiveness of an oronasal mask versus a nasal mask with a chinstrap in controlling excessive leaks. Participants will undergo a controlled crossover trial, where they will use each type of mask for a specified duration, with a washout period in between. The study focuses on patients who have persistent excessive leaks despite previous interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with moderate to severe obstructive sleep apnea who experience excessive unintentional leaks while using nasal CPAP.
Not a fit: Patients with central apnea, severe nasal obstruction, or those with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved CPAP adherence and better management of obstructive sleep apnea symptoms.
How similar studies have performed: While the management of unintentional leaks in CPAP therapy has been explored, this specific comparison of oronasal versus nasal CPAP with chinstrap is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
São Paulo, Brazil
- Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo — São Paulo, Brazil, Brazil (RECRUITING)
Study contacts
- Principal investigator: Pedro Genta — Study Principal Investigator
- Study coordinator: Pedro Genta
- Email: prgenta@gmail.com
- Phone: 551126625486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Continuous Positive Airway Pressure, Adverse Effect, Obstructive Sleep Apnea, CPAP, Excessive leak