Addressing Unintentional Leakage When Using Nasal CPAP - Study B

NCT06570629 | Recruiting

• 1 other identifier: avniocpapn2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 (4)

• CPAP Side-effects questionnaire

  27 days

• Residual apnea-hypopnea index (AHI)

  27 days

• Functional Outcomes of Sleep Questionnaire (FOSQ 10)

  27 days

• Pittsburgh questionnaire

  27 days

Study Arms (2)

Oronasal CPAP

EXPERIMENTAL

CPAP with an oronasal mask for 7 days.

Device: Oronasal CPAP

Chinstrap

EXPERIMENTAL

CPAP with a nasal mask and a chinstrap for 7 days.

Device: Nasal CPAP plus Chinstrap

Interventions

Oronasal CPAP DEVICE

In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.

Oronasal CPAP

Nasal CPAP plus Chinstrap DEVICE

In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.

Chinstrap

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 drops of leak over one night of nasal CPAP
• Persistence of excessive leak at the end of Study A.

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 (1)

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

São Paulo, Brazil, 55, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Pedro Genta

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Genta

CONTACT

551126625486; prgenta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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 (1)