Clinical trial NCT06570616: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Continuous Positive Airway Pressure
Adverse Effect
Obstructive Sleep Apnea
Keywords: CPAP
Excessive leak
Obstructive Sleep Apnea
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: SUPPORTIVE_CARE

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.

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.

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).

Primary outcomes:
measure: 95th CPAP unintentional leak
timeFrame: 27 days
Secondary outcomes:
measure: CPAP Side-effects questionnaire
timeFrame: 27 days
Other outcomes:
measure: CPAP level
timeFrame: 27 days
measure: Residual apnea-hypopnea index (AHI)
timeFrame: 27 days
measure: Functional Outcomes of Sleep Questionnaire (FOSQ 10)
timeFrame: 27 days
measure: Pittsburgh questionnaire
timeFrame: 27 days
Locations:
city: São Paulo
country: Brazil
facility: InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
state: SP
city: Sao Paulo
country: Brazil
facility: Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
Study officials:
affiliation: Study Principal Investigator
name: Pedro Genta
role: PRINCIPAL_INVESTIGATOR
References: