First-generation OTC Antihistamine Use and Voice Function: A Preliminary Study
Status:
Not yet recruiting
Trial end date:
2024-05-15
Target enrollment:
Participant gender:
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.