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Trial · NCT07895654

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIH80 Duration Per Event (IH80dpe)24-hour study period (each crossover period)
Average duration per intermittent hypoxemia event with SpO₂ below 80% for at least 10 seconds (IH80dpe), measured in seconds per event per 24-hour study period. Calculated as total cumulative duration of SpO₂ below 80% events divided by the number of events in the 24-hour period.
SecondaryIH80 Frequency24-hour study period (each crossover period)Number of intermittent hypoxemia events with SpO₂ below 80% for at least 10 seconds per 24-hour study period
SecondaryIH85 Frequency24-hour study period (each crossover period)Number of intermittent hypoxemia events with SpO₂ below 85% for at least 10 seconds per 24-hour study period
SecondaryIH85 Duration Per Event (IH85dpe)24-hour study period (each crossover period)Average duration per intermittent hypoxemia event with SpO₂ below 85% for at least 10 seconds, in seconds per event per 24-hour study period
SecondaryIH90 Frequency24-hour study period (each crossover period)Number of intermittent hypoxemia events with SpO₂ below 90% for at least 10 seconds per 24-hour study period
SecondaryIH90 Duration Per Event (IH90dpe)24-hour study period (each crossover period)Average duration per intermittent hypoxemia event with SpO₂ below 90% for at least 10 seconds, in seconds per event per 24-hour study period
SecondaryTime in Target SpO₂ Range24-hour study period (each crossover period)Proportion of time with SpO₂ within the target range of 91-95% per 24-hour study period
SecondaryBradycardia Frequency24-hour study period (each crossover period)Number of bradycardia episodes (heart rate below 100 bpm for at least 10 seconds) per 24-hour study period
SecondaryFraction of Inspired Oxygen (FiO₂)24-hour study period (each crossover period)Median FiO₂ required to maintain SpO₂ within target range during the 24-hour study period
SecondaryTranscutaneous CO₂ (TcCO₂)24-hour study period (each crossover period)Median transcutaneous CO₂ in mmHg during the 24-hour study period
SecondaryNasopharyngeal Pressure (NP Pressure)24-hour study period (each crossover period)Mean nasopharyngeal pressure during the chin strap vs. no-strap period, as a measure of effective CPAP pressure transmission to the airway
SecondaryRespiratory Rate24-hour study period (each crossover period)Median respiratory rate in breaths per minute during the 24-hour study period
SecondaryRespiratory Support Escalation24-hour study period (each crossover period)Occurrence of respiratory support escalation during the 24-hour study period
SecondaryFeeding Intolerance24-hour study period (each crossover period)Occurrence of feeding intolerance during the 24-hour study period, defined as emesis requiring feeding cessation, or abdominal distension requiring NPO status
OtherSevere Bradycardia Frequency (Exploratory)24-hour study period (each crossover period)
Number of severe bradycardia episodes (heart rate below 80 bpm for at least 10 seconds) per 24-hour study period. High within-subject variance is expected; this outcome will be analyzed as exploratory and descriptive only

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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