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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190427043389N4
Enrollment
60
Registered
2023-08-11
Start date
2023-08-27
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Severity of tinnitus symptoms. Condition 2: Insomnia severity. Condition 3: Quality of Life. Tinnitus Insomnia

Interventions

Intervention 1: Intervention group: 8 mg of Betahistine tablets plus Memantine tablets with instructions to take from the first to the seventh day: 5 mg
8th to 14th day: 5 mg twice a day
15th to 21st day: 5 mg in the morning and 10 mg in the evening
From the 22nd day to the 90th day, 10 mg twice a day. Intervention 2: 8 mg Betahistine tablets and placebo.

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamed Ghavimi

Zanjan University of Medical Sciences

Hamed.ghavimi@gmail.com+98 24 3347 3635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026