Addressing Unintentional Leakage When Using Nasal CPAP - Study B

Official title

Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

Overview

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 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.

Interventions

• Device Oronasal CPAP
  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.
• Device Nasal CPAP plus Chinstrap
  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.

Primary outcome measures

• 95th CPAP unintentional leak [Time frame: 27 days]

Secondary outcome measures (4)

• CPAP Side-effects questionnaire [Time frame: 27 days]
• Residual apnea-hypopnea index (AHI) [Time frame: 27 days]
• Functional Outcomes of Sleep Questionnaire (FOSQ 10) [Time frame: 27 days]
• Pittsburgh questionnaire [Time frame: 27 days]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

Brazil · 1 center

• Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universida — São Paulo

Identifiers

NCT: NCT06570629 · avniocpapn2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗