Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus

Launched by CHINESE UNIVERSITY OF HONG KONG · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called low-intensity transcranial ultrasound stimulation (TUS) to help older adults who have chronic tinnitus (ringing in the ears) and sleep disturbances. Tinnitus can make it hard to sleep and may affect the brain's ability to function properly, especially in elderly patients, leading to challenges like memory problems. The trial aims to see if this treatment can safely reduce the severity of tinnitus and improve sleep quality, as well as cognitive functions, over a period of two weeks.

Eligible participants for this study are Chinese, right-handed adults aged 60 to 80 who have been experiencing tinnitus for at least three months and have trouble sleeping, as indicated by a specific sleep quality score. Participants will be randomly assigned to receive either the actual TUS treatment or a placebo (sham TUS) that doesn’t have any real effect. Throughout the trial, their sleep quality, cognitive performance, and overall quality of life will be assessed at different points—before and after the treatment. This study is not yet recruiting participants, but it represents an important step in exploring non-drug options for individuals facing these challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chinese, right-handed, aged from 60 to 80 years.
• • Chronic tinnitus is defined as tinnitus with a duration of at least 3 months. Depending on the justification, different time course definitions of chronic tinnitus are possible.
• • Sleep disturbances are defined as a Pittsburgh Sleep Quality Index (PSQI) total score above 5.
• • No interference with independence in everyday activities.
• Exclusion Criteria:
• • Diseases of ear canal and tympanic membrane checked by otoscopic examination.
• • Previous diagnosis of Meniere's disease and acoustic neuromas.
• • Past history of neurological or mental disorders.
• • Physically frail affecting attendance to treatment sessions.
• • Already attending regular treatments, such as cognitive behavioral therapy or music therapy.
• • Taking a psychotropic or other medication known to affect hearing functions.
• • Significant communicative impairments.