Sleep Disorders Trial, Recruiting NCT06570629 Sponsor: University of Sao Paulo General Hospital Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06570629
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with moderate or severe obstructive sleep apnea (a condition where breathing repeatedly stops during sleep)
  • People who are currently using a CPAP machine with a nasal mask to treat their sleep apnea
  • People whose CPAP data from the last 7 days shows a high level of unintended air leakage (above 24 litres per minute at the 95th percentile), or at least 4 sudden drops in leak over a single night
  • People who still have ongoing excessive air leakage at the end of the first part of the study (called Study A)

Who may not be able to join:

  • People who experience unintended air leaking from their mask or mask accessories (confirm with trial site, as this appears to overlap with inclusion criteria)
  • People whose sleep study showed that central apnea — a type where the brain fails to signal the breathing muscles — was the main finding, rather than obstructive sleep apnea
  • People with unstable heart disease, those who are confined to bed, or those living with a neurodegenerative disease, a severe psychiatric condition, or chronic obstructive pulmonary disease (COPD)
  • People who have previously had surgery to treat obstructive sleep apnea
  • People with severe nasal blockage, as measured by a score of 55 or higher on a standard nasal symptom questionnaire called the NOSE scale

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Pedro Genta, Study Principal Investigator

Phone: 551126625486

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
30 April 2025
Est. completion
31 December 2025

Where this trial is recruiting

🇧🇷 Brazil

Primary endpoints

95th CPAP unintentional leak

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov