Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Continuous Positive Airway Pressure; Adverse Effect
• Intervention / Treatment: Device: APAP (automatic mode); Device: CPAP (fixed mode)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Genta; Phone Number: 551126615486; Email: prgenta@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 55
    • Recruiting
    • Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
    • Contact: Pedro R Genta, MD; Phone Number: 551126625486; Email: prgenta@usp.br
    • Contact: Ivana Rosanelli; Phone Number: 11950782221; Email: ivanarosanelli2107@gmail.com
  • SP
    • São Paulo, SP, Brazil, 03134-002
      • Recruiting
      • InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
      • Contact: PEDRO R GENTA; Phone Number: +55 11 99343-7027; Email: prgenta@gmail.com
      • Contact: IVANA ROSANELLI; Phone Number: +55 11 950782221; Email: ivanarosanelli2107@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AutoCPAP; Subjects will use auto CPAP during 7 days.	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.
Experimental: Fixed; Subjects will start with the CPAP level obtained during auto-CPAP titration. CPAP will be decreased according to the study protocol.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
95th CPAP unintentional leak	The 95th unintentional leak percentile value will be compared during both interventions	27 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual apnea-hypopnea index (AHI)	Residual AHI will be compared during both interventions	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.	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.	27 days
CPAP level	CPAP level will be compared during both interventions	27 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Pedro Genta, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; CPAP; Excessive leak
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: avniocpapn1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No