Addressing Unintentional Leakage When Using Nasal CPAP - Study A

ConditionsContinuous Positive Airway Pressure Adverse Effect Obstructive Sleep Apnea

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 volunteers

Qualifiers

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

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

CPAP (fixed mode)
Device
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.
APAP (automatic mode)
Device
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: AutoCPAPExperimental treatment 1 intervention

Group B: FixedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

95th CPAP unintentional leak

The 95th unintentional leak percentile value will be compared during both interventions

Time frame

27 days

Secondary outcomes

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 days

Other outcomes

CPAP level

CPAP level will be compared during both interventions

Time frame

27 days

Residual apnea-hypopnea index (AHI)

Residual AHI will be compared during both interventions

Time frame

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.

Time frame

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.

Time frame

27 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov

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