Addressing Unintentional Leakage When Using Nasal CPAP - Study A
NCT Number: NCT06570616
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Continuous Positive Airway Pressure|Adverse Effect|Obstructive Sleep Apnea
Interventions: DEVICE: CPAP (fixed mode)|DEVICE: APAP (automatic mode)
Sponsor: University of Sao Paulo General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2026-12-31
Locations: Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo, Sao Paulo, 55, Brazil

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.

Primary Outcome Measures: 95th CPAP unintentional leak, The 95th unintentional leak percentile value will be compared during both interventions, 27 days
Secondary Outcome Measures: CPAP Side-effects questionnaire, This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale., 27 days
Other Outcome Measures: CPAP level, CPAP level will be compared during both interventions, 27 days|Residual apnea-hypopnea index (AHI), Residual AHI will be compared during both interventions, 27 days|Functional Outcomes of Sleep Questionnaire (FOSQ 10), The FOSQ 10 aims to assess the impacts of daytime sleepiness on daily activities. The FOSQ 10 consists of 10 questions comprising 5 items: General productivity, alertness, activity level, social outcomes, and intimate and sexual relationships. Each item generates a score from 1 to 4, and for items with more than one question, the average of the scores is calculated. The overall score is given by multiplying the average of the item scores by 5, obtaining a value from 5 to 20. The higher the score, the better the individual's functional status., 27 days|Pittsburgh questionnaire, The Pittsburgh questionnaire assessed sleep quality over the past month. The questionnaire consists of 19 self-reported questions and 5 questions related to the roommate/bed partner that are not included in the overall score. The 19 self-reported questions are divided into 7 components (respectively, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime sleep dysfunction), and each component is scored on a scale of 0 to 3. The scores are then summed to form an overall scale of 0 to 21 points. The higher the score, the worse the sleep quality, and a PSQI greater than 5 indicates poor sleep quality., 27 days