Addressing Unintentional Leakage When Using Nasal CPAP - Study A

NCT06570616 | Recruiting

• 1 other identifier: avniocpapn1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Continuous Positive Airway Pressure; Adverse Effect; Obstructive Sleep Apnea

Keywords

CPAP; Excessive leak; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 95th CPAP unintentional leak

  The 95th unintentional leak percentile value will be compared during both interventions

  27 days

Secondary Outcomes (1)

• CPAP Side-effects questionnaire

  27 days

Other Outcomes (4)

• CPAP level

  27 days

• Residual apnea-hypopnea index (AHI)

  27 days

• Functional Outcomes of Sleep Questionnaire (FOSQ 10)

  27 days

Study Arms (2)

AutoCPAP

EXPERIMENTAL

Subjects will use auto CPAP during 7 days.

Device: APAP (automatic mode)

Fixed

EXPERIMENTAL

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)

Interventions

CPAP (fixed mode) 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

APAP (automatic mode) 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.

AutoCPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate and severe obstructive sleep apnea;
• Use of CPAP with a nasal mask;
• th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

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

São Paulo, Brazil, 55, Brazil

RECRUITING

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 03134-002, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Pedro Genta

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Genta

CONTACT

551126615486; prgenta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: CPAP device screen is taped to hide CPAP level and mode
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: August 26, 2024
• Study Start: April 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)