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NCT05858216 · ClinicalTrials.gov registry record · Early Phase 1
First-generation OTC Antihistamine Use and Voice Function: A Preliminary Study
A Early Phase 1 study, sponsored by Auburn University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT05858216: Completed Early Phase 1 study, sponsored by Auburn University.
NCT05858216 is a Early Phase 1 study that has completed, run by Auburn University. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05858216, a Early Phase 1 study, has completed, sponsored by Auburn University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn about voice function before and 3 hours after administration of first generation over-the-counter antihistamine in individuals who have been medically diagnosed with allergies and routinely take over-the-counter (OTC) antihistamines for allergy symptoms. The main questions are: 1. Do first generation OTC antihistamines make voice function worse as measured via voice acoustic and aerodynamic measures? It is hypothesized that all objectives measures will reflect a negative change in voice function. 2. Do first generation OTC antihistamines make voice function worse as measured via participant and researcher perceptual measures? It is hypothesized that participants will rate their vocal function as more effortful after taking the antihistamine and researchers will rate voice quality as worse. Participants ages 18-35 who have been diagnosed with allergies, are free of laryngeal pathology, and meet inclusion criteria will be consented. Participation in the study involves a pretrial visit and one day of data collection. The initial visit will obtain informed consent and train the trial measures. The 2nd day involves determination of systemic hydration (\<1.02 g/ml), administration of the OTC antihistamine (Chlor-Trimeton), and measures taken at baseline and 3 hours after antihistamine administration. This antihistamine was selected for its lower sedation and anticholinergic effects than its other first-generation options. Each participant will take one, 12mg tablet. Onset action time for this antihistamine is 3 hours. Participants will be given water to consume during the 3 hour wait for the 2nd data time point to maintain hydration. Measures include routine clinical perceptual, acoustic, aerodynamic, and laryngeal imaging measures.
Primary Outcome
Objective measurement of systemic hydration
Interventions
- DRUG Chlor-Trimeton.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2024-04-23 |
| Phase | Early Phase 1 |
What the finished NCT05858216 record still lists
NCT05858216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Chlor-Trimeton. is the first listed.
NCT05858216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05858216 about?
NCT05858216 is a clinical study titled "First-generation OTC Antihistamine Use and Voice Function: A Preliminary Study". The goal of this clinical trial is to learn about voice function before and 3 hours after administration of first generation over-the-counter antihistamine in individuals who have been medically diagnosed with allergies and routinely take over-the-counter (OTC) antihistamines for allergy symptoms. T...
What is the current status of trial NCT05858216?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2023-06-13. Estimated completion is 2024-04-23.
What interventions are being tested in trial NCT05858216?
The interventions under investigation include: Chlor-Trimeton. (DRUG).
Who is sponsoring clinical trial NCT05858216?
This trial is sponsored by Auburn University, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05858216's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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