Addressing Unintentional Leakage When Using Nasal CPAP - Study A

Official title

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

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 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.

Interventions

• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (1)

• CPAP Side-effects 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 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).

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

Single blind

Primary purpose

Supportive care

Study locations

Brazil · 2 centers

• Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universida — São Paulo
• InCor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo

Identifiers

NCT: NCT06570616 · avniocpapn1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗