An interventional study of Oronasal CPAP and Nasal CPAP plus Chinstrap in Continuous Positive Airway Pressure, Adverse Effect and Obstructive Sleep Apnea, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Supportive care
Among 13 studies in Sleep Apnea, Obstructive by University of Sao Paulo General Hospital — 2 open to participants now, 3 under way, none of them phase 3. Sleep Apnea, Obstructive · University of Sao Paulo General Hospital.
Among the 13 studies in Sleep Apnea, Obstructive by University of Sao Paulo General Hospital, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2025, is one of 10 with no phase, and was the 12th registered.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →2 of the 13 studies in Sleep Apnea, Obstructive by University of Sao Paulo General Hospital are open now, in 1 country. Recruiting first, the newest first:
University of Sao Paulo General Hospital · Sites in Brazil
By country, each count listing its studies:
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 145 (46%) set no upper age limit and 125 (40%) stop at 75 or younger; 53 take children under 18; 65 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 50 is close to the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 50 across the 11 interventional studies, 133 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Sleep Apnea, Obstructive by University of Sao Paulo General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CPAP with an oronasal mask for 7 days.
Device: Oronasal CPAP
CPAP with a nasal mask and a chinstrap for 7 days.
Device: Nasal 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.
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.
95th CPAP unintentional leak
The 95th unintentional leak percentile value will be compared during both interventions
Time frame: 27 days
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Dec 2025, 8 months later.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 8 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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