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NCT05168501 · ClinicalTrials.gov registry record · NA
Assessing Variability of the Ventilatory Response to Duffin's Rebreathing Procedure
A NA study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT05168501 is a NA study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 7 participants.
The verdict
NCT05168501, a NA study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study 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.
Interventions
- OTHER Rebreathing procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-12-27 |
| Est. Completion | 2022-02-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05168501
The ClinicalTrials.gov registry entry for NCT05168501 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rebreathing procedure is the first listed.
NCT05168501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05168501 about?
NCT05168501 is a clinical study titled "Assessing Variability of the Ventilatory Response to Duffin's Rebreathing Procedure". 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 ...
What is the current status of trial NCT05168501?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2021-12-27. Estimated completion is 2022-02-18.
What interventions are being tested in trial NCT05168501?
The interventions under investigation include: Rebreathing procedure (OTHER).
Who is sponsoring clinical trial NCT05168501?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
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