Addressing Unintentional Leakage When Using Nasal CPAP - Study B
- Conditions
- Adverse EffectObstructive Sleep ApneaContinuous Positive Airway Pressure
- Interventions
- Device: Oronasal CPAPDevice: Nasal CPAP plus Chinstrap
- Registration Number
- NCT06570629
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oronasal CPAP Oronasal CPAP CPAP with an oronasal mask for 7 days. Chinstrap Nasal CPAP plus Chinstrap CPAP with a nasal mask and a chinstrap for 7 days.
- Primary Outcome Measures
Name Time Method 95th CPAP unintentional leak 27 days The 95th unintentional leak percentile value will be compared during both interventions
- Secondary Outcome Measures
Name Time Method Residual apnea-hypopnea index (AHI) 27 days Residual AHI will be compared during both interventions
CPAP Side-effects questionnaire 27 days This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale.
Functional Outcomes of Sleep Questionnaire (FOSQ 10) 27 days 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.
Pittsburgh questionnaire 27 days 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.
Trial Locations
- Locations (1)
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
🇧🇷Sao Paulo, Brazil