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

NCT05858216 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 23-175
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Voice Disorder Due to Iatrogenic Factor

Outcome Measures

Primary Outcomes (9)

• Urine specific gravity (g/ml)

  Objective measurement of systemic hydration

  Start of trial

• Fundamental frequency (Hertz)

  Sustained "a" task from which the cycles of vocal fold vibration per second are extracted.

  Change from Baseline Fundamental Frequency at 3 hours

• Speaking fundamental frequency (Hertz)

  Standard reading task from which the average cycles per second of vocal fold vibration are extracted.

  Change from Baseline Fundamental Frequency at 3 hours

• Harmonic-to-Noise ratio (decibels, dB)

  Sustained "a" task from which a ratio of the harmonic acoustic components of the signal relative to the noise components of the acoustic signal are determined

  Change from Baseline Fundamental Frequency at 3 hours

• Cepstral peak prominence (decibels, dB)

  An acoustic measurement of voice quality deviation that is extracted from a recorded speech sample.

  Change from Baseline Fundamental Frequency at 3 hours

• Phonation threshold pressure (cm/H20)

  An aerodynamic measurement of the minimum amount of subglottal pressure required to initiate vocal fold vibration for voicing

  Change from Baseline Fundamental Frequency at 3 hours

• Videostroboscopy (video of vocal fold vibration)

  Standard clinical endoscopic imaging of laryngeal structure and function

  Change from Baseline Fundamental Frequency at 3 hours

• OMNI-Vocal Effort Scale (scaled score)

  A validated scale of perceived vocal effort that provides a scale of 1-10 from which to determine how much vocal effort was produced.

  Change from Baseline Fundamental Frequency at 3 hours

• Rating-of-Fatigue (ROF; scaled score)

  A validated scale of perceived voice fatigue

  Change from Baseline Fundamental Frequency at 3 hours

Study Arms (1)

Chlor-Trimeton

OTHER

Package recommended dose of over the counter Chlor-Trimeton will be administered to assess voice function before and 3 hours after taking it.

Drug: Chlor-Trimeton.

Interventions

Chlor-Trimeton. DRUG

Package dose of Chlor-Trimeton will be administered

Chlor-Trimeton

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Department of Speech, Language & Hearing Sciences, Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Interventions

Chlorpheniramine

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mary J Sandage, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Within participant repeated measures design

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 15, 2023
• Study Start: June 13, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 23, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)