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

• Status: Not yet recruiting
• Trial end date: 2024-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Auburn University
• Treatments: Chlorpheniramine

Criteria

Inclusion Criteria:

• the ability to match pitch on a screening task

• have diagnosed allergies of the upper airway

• a SNOT-22 score of 20 or greater (19)

• pass videostroboscopic prescreening for laryngeal pathologies

• no history of voice disorder

• ability to comfortably breathe through both their nose and mouth

• no history of drying medications other than the antihistamine, reflux, respiratory diseases, diabetes, neurological problems, hormone imbalance, pregnancy, breastfeeding over the preceding 6 months, or active smoker at the time of investigation.

Exclusion Criteria:

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