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临床试验/NCT07309354
NCT07309354已完成不适用

The Effects of Tizanidine on Acoustic Reflex

Uşak University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年7月15日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Change in Acoustic Reflex Threshold

研究概览

简要总结

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.

详细描述

Tizanidine is a commonly used muscle relaxant prescribed for musculoskeletal pain. Its relaxing effect on body muscles is well known. However, it is not clear whether tizanidine also affects the small middle ear muscle responsible for the acoustic reflex.

The acoustic reflex is a natural protection system of the ear. When a loud sound occurs, a tiny muscle called the stapedius contracts. This contraction reduces the amount of sound energy that reaches the inner ear and helps protect the inner ear and auditory nerve from acoustic damage. If this reflex does not work properly, a person may become more sensitive to loud sounds and may be more vulnerable to noise-related ear injury.

Only a few studies have looked at how muscle relaxant medications influence the acoustic reflex, and most have focused on drugs used during anesthesia. There is very little information about tizanidine, which is used in daily clinical practice for muscle and joint pain. Because of this gap, it is important to understand whether tizanidine changes the strength or timing of the acoustic reflex.

This single-arm clinical study will follow adults who are already planned to receive tizanidine as part of their treatment. Participants will take tizanidine 6 mg by mouth once a day for 1 week. Hearing and acoustic reflex tests will be performed at two time points: before starting tizanidine and at the end of the treatment period. The same standardized audiological methods will be used at both time points, including tympanometry and acoustic reflex measurements in both ears.

The main goal is to compare acoustic reflex measurements before and after tizanidine treatment in the same participants. By evaluating changes in acoustic reflex thresholds, amplitudes, and response patterns, the study aims to determine whether tizanidine has a measurable effect on stapedius muscle function. If the results suggest that tizanidine weakens or delays the acoustic reflex, this could mean that patients taking tizanidine may need to avoid excessive noise exposure during treatment. The findings may help clinicians better understand the auditory safety of muscle relaxant therapy and guide practical advice for patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Tizanidine (Drug)

结局指标

主要结局

Change in Acoustic Reflex Threshold

时间窗: Baseline (before treatment) and Day 7 (end of treatment)

次要结局

未报告次要终点

研究者

发起方
Uşak University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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