The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department

NCT07749573 | Not Yet Recruiting

• 1 other identifier: 2024-KAEK-24/43
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Dizziness is a common reason for emergency department visits. Posterior canal benign paroxysmal positional vertigo (BPPV) is one of the most frequent causes of peripheral vertigo. Intravenous dimenhydrinate is among the standard treatments administered in the emergency setting; however, this and similar drug classes may cause sedation and delay central compensation. This study tests the hypothesis that chewing gum may modulate the vestibular system via trigeminal and cervical neuromuscular pathways, thereby reducing dizziness and nausea symptoms. Patients diagnosed with posterior canal BPPV who are started on intravenous dimenhydrinate will be randomly assigned to two groups: the intervention group will chew sugar-free mint-flavored gum for 20 minutes in addition to standard treatment, while the control group will receive standard treatment only. Dizziness and nausea severity will be assessed using VAS at baseline, 20 minutes, and 60 minutes.

Conditions

Dizziness; Vertigo Benign Positional

Outcome Measures

Primary Outcomes (1)

• Change in dizziness Visual Analog Scale score from baseline to 20 minutes

  The primary outcome is the change in dizziness severity measured using a 10-cm Visual Analog Scale, ranging from 0 (no dizziness) to 10 (worst imaginable dizziness), with higher scores indicating greater dizziness severity, between baseline and 20 minutes after treatment initiation.

  Baseline and 20 minutes after treatment initiation

Secondary Outcomes (1)

• Nausea Visual Analog Scale score at 20 minutes

  20 minutes after treatment initiation

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients receive only the standard treatment initiated by the responsible emergency physician: 50 mg dimenhydrinate in 100 cc 0.9% NaCl administered intravenously

Drug: Dimenhydrinate

Intervention Group

EXPERIMENTAL

In addition to standard treatment (50 mg dimenhydrinate in 100 cc 0.9% NaCl IV), patients receive sugar-free mint-flavored chewing gum simultaneously with the start of treatment and chew it under observation for 20 minutes.

Drug: Dimenhydrinate; Behavioral: Sugar-Free Mint-Flavored Chewing Gum

Interventions

Dimenhydrinate DRUG

Dimenhydrinate 50 mg diluted in 100 mL of 0.9% sodium chloride administered intravenously as standard treatment for posterior canal benign paroxysmal positional vertigo in the emergency department.

Control Group; Intervention Group

Sugar-Free Mint-Flavored Chewing Gum BEHAVIORAL

Participants chew one piece of sugar-free mint-flavored chewing gum under observation for 20 minutes, starting simultaneously with standard intravenous treatment.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years
• Duration of dizziness complaint less than 24 hours
• Posterior canal BPPV diagnosis confirmed by the emergency physician via the Dix-Hallpike test
• Intravenous administration of 50 mg dimenhydrinate in 100 cc 0.9% NaCl initiated by the responsible emergency physician
• Symptomatic dizziness with VAS ≥ 4
• Alert, cooperative, and able to chew gum
• Willingness to participate and provision of written informed consent

You may not qualify if:

• Findings suggestive of central vertigo (vertical nystagmus, diplopia, ataxia, hemiparesis, focal neurological deficit, etc.)
• Pregnancy
• Known gum intolerance, history of allergy to gum or its excipients, temporomandibular joint dysfunction, significant tooth loss, use of dentures or removable prosthetics that would prevent chewing
• Altered level of consciousness
• Central pathology detected on investigations performed during the visit
• Hemodynamic and/or respiratory instability
• Diagnosis other than posterior canal BPPV as the cause of vertigo
• Treatment other than pharmacological therapy planned or already administered by the responsible emergency physician
• Active vomiting at the time of enrollment
• Severe dizziness with VAS ≥ 8 (excluded due to high likelihood of requiring additional treatment, risk of protocol deviation, and safety concerns regarding gum chewing)
• Patients who initially consented but subsequently wish to withdraw from the study

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Dizziness

Interventions

Dimenhydrinate

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Intervention Hierarchy (Ancestors)

Diphenhydramine; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

TU (1)