Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-07-15
2026-03-15
Brief Summary
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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.
Detailed Description
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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 hearing 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 medicines influence the acoustic reflex, and most of them 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 done twice: once before starting tizanidine and again 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 the acoustic reflex measurements before and after tizanidine treatment in the same participants. By looking at changes in acoustic reflex thresholds, amplitudes, and response patterns, the study aims to show 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 be more careful about exposure to loud noise during treatment. The findings may help clinicians better understand the auditory safety of muscle relaxant therapy and guide practical advice for patients.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Tizanidine Pre-Post Evaluation
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.
Tizanidine
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.
Interventions
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Tizanidine
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Uşak University
OTHER
Responsible Party
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Locations
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Uşak University Faculty of Medicine
Uşak, Merkez, Turkey (Türkiye)
Countries
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Central Contacts
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Faruk Kadri Bakkal, MD, Asistant Professor
Role: CONTACT
Phone: +905059242255
Email: [email protected]
Facility Contacts
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Faruk Kadri Bakkal
Role: primary
Kağan Özkuk
Role: backup
Other Identifiers
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USAKBAP2025671
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TIZAR470
Identifier Type: -
Identifier Source: org_study_id