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The effectiveness of the combination of Memantine and Betahistine on insomnia severity, quality of life and severity of symptoms in people with primary tinnitus

Phase 3
Conditions
Condition 1: Severity of tinnitus symptoms. Condition 2: Insomnia severity. Condition 3: Quality of Life.
Tinnitus
Insomnia
H93.1
G47.0
Registration Number
IRCT20190427043389N4
Lead Sponsor
Zanjan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
60
Inclusion Criteria

Having primary tinnitus for more than 3 months
Willingness and interest to participate in the study
Having moderate intensity of insomnia (scoring more than 15 based on the ISI Insomnia Severity Questionnaire)

Exclusion Criteria

Tinnitus due to anatomical disease
tumor
Previous use of memantine
History of high blood pressure
Suffering from chronic and debilitating diseases as diagnosed by the attending physician
Known mental illness
Concomitant use of medications that interact with memantine
contraindication of memantine by the doctors diagnosis

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of tinnitus intensity. Timepoint: Before intervention and 3 months after the start of the intervention. Method of measurement: Tinnitus severity index standard questionnaire.
Secondary Outcome Measures
NameTimeMethod
Insomnia severity. Timepoint: Before the start of the intervention and 3 months after the start of the intervention. Method of measurement: ISI Insomnia Severity Index Questionnaire.;Quality of Life. Timepoint: Before the start of the intervention and 3 months after the start of the intervention. Method of measurement: Standard Quality of Life Questionnaire (SF-36).
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