Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Not Applicable

Recruiting

• Conditions: Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Adverse Effect
• Interventions: Device: APAP (automatic mode); Device: CPAP (fixed mode)

• Registration Number: NCT06570616
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-27
• Study Start: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AutoCPAP	APAP (automatic mode)	Subjects will use auto CPAP during 7 days.
Fixed	CPAP (fixed mode)	Subjects will start with the CPAP level obtained during auto-CPAP titration. CPAP will be decreased according to the study protocol.

Primary Outcome Measures

Name	Time	Method
95th CPAP unintentional leak	27 days	The 95th unintentional leak percentile value will be compared during both interventions

Secondary Outcome Measures

Name	Time	Method
CPAP Side-effects questionnaire	27 days	This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale.

Trial Locations

Locations (2)

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP; 🇧🇷 São Paulo, SP, Brazil

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo; 🇧🇷 Sao Paulo, Brazil