Tizanidine and Acoustic Reflex

NCT07309354 | Recruiting DMC

• 2 other identifiers: TIZAR470USAKBAP2025671
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how the muscle relaxant tizanidine affects the acoustic reflex in adults. The acoustic reflex is a natural protection system of the ear that helps reduce the impact of loud sounds. It is not known whether tizanidine changes how this reflex works. The main question this study aims to answer is: Does taking tizanidine for 1 week change acoustic reflex thresholds in the same person, when comparing before and after treatment? Participants who receive tizanidine will undergo hearing and acoustic reflex tests before treatment and again at the end of the treatment period.

Conditions

Reflex, Acoustic; Hearing

Keywords

tizanidine; acıustic reflex; hearing

Outcome Measures

Primary Outcomes (1)

• Change in Acoustic Reflex Threshold

  Baseline (before treatment) and Day 7 (end of treatment)

Study Arms (1)

Tizanidine Pre-Post Evaluation

EXPERIMENTAL

Participants in this single-arm study will receive tizanidine 6 mg orally once daily for 1 week. Standardized audiological testing, including tympanometry and acoustic reflex measurements, will be performed twice: once before starting tizanidine and again at the end of the treatment period. Pre- and post-treatment acoustic reflex thresholds and response patterns will be compared within the same participants.

Drug: Tizanidine

Interventions

Tizanidine DRUG

Participants will receive tizanidine 6 mg orally once daily for 1 week. Standardized audiological testing, including tympanometry and multifrequency acoustic reflex measurements, will be performed before starting treatment and on day 7 at the end of the treatment period to evaluate changes in acoustic reflex thresholds and response patterns.

Tizanidine Pre-Post Evaluation

Eligibility Criteria

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

You may qualify if:

• Voluntary participation and ability to provide informed consent
• Age 18 years or older
• Currently receiving tizanidine 6 mg once daily as part of clinical care
• No active middle ear disease that could affect tympanometric or acoustic reflex measurements
• No chronic neuromuscular disease
• Ability to complete audiological testing

You may not qualify if:

• Refusal to participate
• Withdrawal of consent at any time
• Age under 18 years
• Presence of any ear condition that affects the acoustic reflex (e.g., otitis media, tympanic membrane perforation, otosclerosis)
• Presence of chronic neuromuscular disease
• Current alcohol or substance use disorder
• Any condition preventing completion of acoustic reflex or tympanometry testing

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak University Faculty of Medicine

Uşak, Merkez, 64420, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

tizanidine

Central Study Contacts

Faruk Kadri Bakkal, MD, Asistant Professor

CONTACT

+905059242255; faruk.bakkal@usak.edu.tr

Kağan Özkuk, MD, Professor

CONTACT

+905055601815; kagan.ozkuk@usak.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: July 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)