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Addressing Unintentional Leakage When Using Nasal CPAP - Study B

Key facts

Who runs it
University of Sao Paulo General Hospital
Where
Brazil1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
50 people, planned
Started
30 Apr 2025
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Oronasal CPAP
  • Nasal CPAP plus Chinstrap
Record updated
30 April 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous surgery for obstructive sleep apnea
  • Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD
  • Patients who experience unintentional leakage from the mask/accessories
  • Diagnostic polysomnography examination with a predominance of central apnea
  • Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Oronasal CPAPTreatment being tested

    CPAP with an oronasal mask for 7 days.

  • ChinstrapTreatment being tested

    CPAP with a nasal mask and a chinstrap for 7 days.

    Treatment: Nasal CPAP plus Chinstrap

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
Record updated
30 April 2025