Addressing Unintentional Leakage When Using Nasal CPAP - Study B

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Adverse Effect; Continuous Positive Airway Pressure; Obstructive Sleep Apnea

Treatments: Device: Nasal CPAP plus Chinstrap; Device: Oronasal CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06570629

avniocpapn2

Details and patient eligibility

About

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.

Full description

Study B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive leak at the end of study A. The order of interventions will be randomized. One of the groups will initially use an oronasal mask for 10 days. A washout period of 7 days under nasal CPAP will follow. After washout, subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days. In the other group, the order of interventions will be the opposite.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Oronasal CPAP

Experimental group

Description:

CPAP with an oronasal mask for 7 days.

Treatment:

Device: Oronasal CPAP

Chinstrap

Experimental group

Description:

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

Treatment:

Device: Nasal CPAP plus Chinstrap