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 the severity of insomnia, quality of life and severity of symptoms in people with primary tinnitus

Phase 3 randomized clinical trial with parallel groups, with a control group, single-blind, will be conducted on 60 patients. For randomization, 15 blocks will be selected using the random number table (blocks of 4) so that the sample size reaches 60 people.

The research setting includes the neurology clinic of Vali Asr Medical Training Center in Zanjan and the research community includes all people with primary tinnitus who refer to the center. Individuals will be selected by the available method and then randomly assigned to the intervention group, Betahistine plus Memantine, and the control group, Betahistine plus placebo. In this study, only patients will be blinded.

Inclusion criteria: suffering from tinnitus disease for more than 3 months, age 18 to 60 years, having moderate intensity of insomnia. Exclusion criteria: Tinnitus due to anatomical disorder, tumor, previous use of Memantine, history of high blood pressure, suffering from chronic and debilitating diseases, recognized mental illness, concurrent use of drugs that interfere with Memantine, contraindication to use of Memantine

The intervention group will receive Betahistine tablets (8 mg daily) plus Memantine for up to three months. The schedule for receiving Memantine is as follows: Day 1 to 7: 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 The control group will receive Betahistine tablets (8 mg daily) and placebo.

Severity of insomnia, quality of life and severity of tinnitus symptoms

Eligible people will be selected from the usual referrals to the neurology clinic of Vali Asr Zanjan educational center by the available method and then will be allocated to two groups by random block method (blocks of 4). The first group will receive Betahistine plus Memantine and the second group will receive Betahistine plus placebo. For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 15 blocks so that the sample size reaches 60 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.

In this study, people will be assigned to two groups by random block method (blocks of 4). Patients will be blinded in this study. One group will receive Betahistine tablets along with Memantine tablets, while the other group will receive Betahistine tablets along with a placebo. Placebo tablets are very similar to Memantine tablets in terms of color, shape and size, but do not contain the active drug. Both pills are manufactured by the same pharmaceutical company.

Part of the data, such as the information related to the main outcome, can be shared.

three months

researchers

A person can access the data after requesting the person in charge of the trial and checking her reliability.

Central Library of Zanjan University of Medical Sciences

A person can access the data after requesting the person in charge of the trial and checking her reliability.