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First-generation OTC Antihistamine Use and Voice Function: A Preliminary Study

NCT05858216 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-04-24

No results posted yet for this 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.

Conditions

  • Voice Disorder Due to Iatrogenic Factor

Interventions

DRUG

Chlor-Trimeton.

Package dose of Chlor-Trimeton will be administered

Sponsors & Collaborators

  • Auburn University

    lead OTHER

Principal Investigators

  • Mary J Sandage, PhD · Auburn University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2024-04-15
Completion
2024-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05858216 on ClinicalTrials.gov