Addressing Unintentional Leakage When Using Nasal CPAP - Study A

NCT ID: NCT06570616

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-12-31

Brief 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. 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.

Conditions

Continuous Positive Airway Pressure; Adverse Effect; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

AutoCPAP

Subjects will use auto CPAP during 7 days.

Group Type: EXPERIMENTAL

APAP (automatic mode)

Intervention Type: 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.

Fixed

Subjects will start with the CPAP level obtained during auto-CPAP titration. CPAP will be decreased according to the study protocol.

Group Type: EXPERIMENTAL

CPAP (fixed mode)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility 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 leak line drop events

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pedro Rodrigues Genta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro Genta

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, Brazil, Brazil

Site Status: RECRUITING

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Pedro Genta

Role: CONTACT

prgenta@gmail.com

551126615486

Facility Contacts

Pedro R Genta, MD

Role: primary

prgenta@usp.br

551126625486

Ivana Rosanelli

Role: backup

ivanarosanelli2107@gmail.com

11950782221

PEDRO R GENTA

Role: primary

prgenta@gmail.com

+55 11 99343-7027

IVANA ROSANELLI

Role: backup

ivanarosanelli2107@gmail.com

+55 11 950782221

Other Identifiers

avniocpapn1

Identifier Type: -

Identifier Source: org_study_id