NCT05168501

Assessing Variability of the Ventilatory Response to Duffin's Rebreathing Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Ventilation
• Reproducibility
• Physiology

Interventions

Type	Name	Description
OTHER	Rebreathing procedure	Paired Duffin's rebreathing procedures performed two different isoxic end tidal PO2 levels (i.e., hyperoxic and hypoxic conditions) will be performed on Day 1 at 0, 2, 4, 6, and 24 hours.

Timeline

• Start date: 2021-12-27
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2021-12-23
• Last updated: 2024-07-15
• Results posted: 2024-07-15

Locations

1 site across 1 country: United States