Continuous Positive Airway Pressure, Adverse Effect, Obstructive Sleep Apnea
Conditions
Keywords
CPAP, Excessive leak, Obstructive Sleep Apnea
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.
Interventions
DEVICEOronasal CPAP
In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
DEVICENasal CPAP plus Chinstrap
In this crossover trial, subjects will use CPAP with either an oronasal mask or a. nasal mask with a chinstrap for 7 days. The order of each intervention will be randomized.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 95th CPAP unintentional leak | 27 days | The 95th unintentional leak percentile value will be compared during both interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
Primary ContactPedro Genta
Outcome results
None listed