Last reviewed · How we verify
NCT06570616
Addressing Unintentional Leakage When Using Nasal CPAP - Study A
NA trial testing CPAP (fixed mode) in Continuous Positive Airway Pressure in 100 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 100 |
| Start date | 30 April 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2028 |
| Sites | 2 locations across Brazil |
Drugs / interventions tested
- CPAP (fixed mode)
- APAP (automatic mode)
Conditions studied
- Continuous Positive Airway Pressure — all drugs for Continuous Positive Airway Pressure →
- Adverse Effect — all drugs for Adverse Effect →
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
University of Sao Paulo General Hospital
Who can join
18 and older, any sex, with Continuous Positive Airway Pressure or Adverse Effect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06570616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Continuous Positive Airway Pressure
Currently open trials in the same condition.
- NCT06570629 — Addressing Unintentional Leakage When Using Nasal CPAP - Study B · NA · recruiting
- NCT06542263 — Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA · recruiting
Other University of Sao Paulo General Hospital trials
Trials by the same sponsor.
- NCT07275580 — Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases · Phase 4 · not yet recruiting
- NCT07478094 — Longitudinal Outcomes of Patients With Group 3 Pulmonary Hypertension Treated With Iloprost · not yet recruiting
- NCT07341386 — Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases · Phase 4 · not yet recruiting
- NCT07242092 — Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs · Phase 4 · not yet recruiting
- NCT07484152 — Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Essential Tremor · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06570616 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 30 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06570616.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing