Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Oronasal CPAP
DeviceIn 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.
Nasal CPAP plus Chinstrap
DeviceIn 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Oronasal CPAPExperimental treatment 1 intervention
Group B: ChinstrapExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
95th CPAP unintentional leak
The 95th unintentional leak percentile value will be compared during both interventions
Time frame
27 daysSecondary outcomes
1
CPAP Side-effects questionnaire
This questionnaire addresses CPAP side-effects including those related to excessive air leak using a visual-analog scale.
Time frame
27 days2
Residual apnea-hypopnea index (AHI)
Residual AHI will be compared during both interventions
Time frame
27 days3
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.
Time frame
27 days4
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.
Time frame
27 daysSponsors and contacts
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Source ClinicalTrials.gov