Adults 18 to 50, any sex, with Ventilation or Reproducibility. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Baseline Minute VentilationPrimary· 0, 2, 4, 6 and 24 hours
Minute ventilation during the rebreathing assessment when end tidal PCO2 (partial pressure carbon dioxide) is less than the ventilatory recruitment threshold (represents non-chemoreflex drives to breathe; 'flat' portion of minute ventilation versus end tidal PCO2 relationship). Data was analyzed using linear-mixed effects regression of baseline minute ventilation with random effects for between subject, between day, and between occasion variability. Reported value is the mean for the treatment group across all individuals, days, and times.
Group
Value
95% CI
Hyperoxic Rebreathing
11.6
± 3.4
Hypoxic Rebreathing
12.0
± 2.9
Ventilatory Recruitment ThresholdPrimary· 0, 2, 4, 6 and 24 hours
The end tidal PCO2 point above which minute ventilation starts to increase linearly with further increases in end tidal PCO2. Data was analyzed using linear-mixed effects regression of ventilatory recruitment threshold with random effects for between subject, between day, and between occasion variability. Reported value is the mean for the treatment group across all individuals, days, and times.
Group
Value
95% CI
Hyperoxic Rebreathing
43.0
± 3.0
Hypoxic Rebreathing
38.1
± 1.7
Slope of the PCO2-ventilatory Response CurvePrimary· 0, 2, 4, 6 and 24 hours
Slope of the minute ventilation versus end tidal PCO2 curve that reflects the increase in minute ventilation relative to the increase in end tidal PCO2. Data was analyzed using linear-mixed effects regression of Slope of the PCO2-ventilatory response curve with random effects for between subject, between day, and between occasion variability. Reported value is the mean for the treatment group across all individuals, days, and times.
Intersection of the slope of the PCO2-ventilation response curve with the X axis. Data was analyzed using linear-mixed effects regression of extrapolated ventilatory recruitment threshold with random effects for between subject, between day, and between occasion variability. Reported value is the mean for the treatment group across all individuals, days, and times.
Group
Value
95% CI
Hyperoxic Rebreathing
36.8
± 7.1
Hypoxic Rebreathing
32.7
± 5.9
Sponsor's own description
This study will combine Duffin's rebreathing procedure with additional study procedures, such as quantitative pupillometry, that are planned for subsequent clinical studies in order to confirm feasibility and gather reproducibility data using the procedure. The reproducibility of Duffin rebreathing has been assessed previously by Mahamed and Duffin (2001) performing hyperoxic and hypoxic rebreathing procedures measured once daily for 14 consecutive days and then by Jensen et al. (2010) performing 4 pairs of hyperoxic and hypoxic rebreathing procedures in 1 day followed by 1 pair on 4 additional days separated by weeks to more than a month.
The present study is an unblinded reproducibility assessment to assess variability of the ventilatory response to Duffin's rebreathing procedure. Subjects will report to the study site for screening between Days -28 to -2 and then will return to the site on Day -1 for baseline assessments and check-in. After check-in (Day -1), subjects will remain in study site for PD assessments on Day 1 and check out on Day 2.
Paired rebreathing procedures (i.e., at two different isoxic end tidal PO2 \[partial pressure oxygen\] levels) will be performed on Day 1 at 0, 2, 4, and 6 hours. An additional pair of rebreathing procedures will be performed on Day 2 before checkout (approximately 24 hours). Subjects will not be administered any drugs in this study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Food and Drug Administration (FDA)
Last refreshed: 15 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05168501.