Clinical trial NCT06570629: Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Official title: Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
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: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 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.

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).

Primary outcomes:
measure: 95th CPAP unintentional leak
timeFrame: 27 days
Secondary outcomes:
measure: CPAP Side-effects questionnaire
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
Other outcomes:
Locations:
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: