Adverse Effect, Continuous Positive Airway Pressure, 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 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.
Interventions
DEVICECPAP (fixed mode)
Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.
DEVICEAPAP (automatic mode)
Patients will undergo strategies to control excessive leakage while using autoCPAP vs. progressively decreasing fixed nasal CPAP. Before randomization, subjects will undergo an autoCPAP titration for 3 days. Subjects will then be randomized to start the protocol with autoCPAP or fixed CPAP and then will switch to the alternative arm.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
CPAP device screen is taped to hide CPAP level and mode
Intervention model description
Crossover Assignment
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 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).
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 |
|---|---|---|
| CPAP Side-effects questionnaire | 27 days | This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| CPAP level | 27 days | CPAP level will be compared during both interventions |
| Residual apnea-hypopnea index (AHI) | 27 days | Residual AHI will be compared during both interventions |
| 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