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Not yet recruiting NCT07749573

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

No phase Interventional Vertigo Benign Positional Dizziness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dimenhydrinate, Sugar-Free Mint-Flavored Chewing Gum.
Who it may be relevant to
Registry conditions: Vertigo Benign Positional, Dizziness. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Chewing Gum in Addition to Standard Treatment on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department: A Randomized Controlled Clinical Trial

Overview

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.

Interventions

  • Drug Dimenhydrinate
    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.
  • Behavioral Sugar-Free Mint-Flavored Chewing Gum
    Participants chew one piece of sugar-free mint-flavored chewing gum under observation for 20 minutes, starting simultaneously with standard intravenous treatment.

Primary outcome measures

  • Change in dizziness Visual Analog Scale score from baseline to 20 minutes [Time frame: Baseline and 20 minutes after treatment initiation]
Secondary outcome measures (1)
  • Nausea Visual Analog Scale score at 20 minutes [Time frame: 20 minutes after treatment initiation]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Atatürk Sanatorium Training and Research Hospital — Ankara

Identifiers

NCT: NCT07749573 · 2024-KAEK-24/43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗