Efficacy of Hearing-aid Treatment on Sound Perception and Residual Hearing Preservation for Patients With Tinnitus and Co-existing Hearing Loss: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tinnitus, Subjective
- Sponsor
- Eye & ENT Hospital of Fudan University
- Enrollment
- 62
- Primary Endpoint
- tinnitus handicap inventory (THI)
- Last Updated
- 4 years ago
Overview
Brief Summary
Considering the extent to which HAs play a role in sound perception and residual hearing preservation among patients with tinnitus and co-existing HL remains a lack of compelling extensive evidence, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the HA treatment group, and the other is the waiting list control (WLC) group which receives no interventions during this period.
Detailed Description
In clinical practice, chronic subject tinnitus poses an important challenge. This condition can negatively affect an individual's emotional and functional well-being. In most cases, tinnitus is highly associated with hearing impairment, particularly in cases of high-frequency sensorineural hearing loss (SNHL). The occurrence of tinnitus in patients with HL is one of the most prevalent sensory disabilities, causing a deleterious effect on patients' lives. Nowadays, the mild to moderate SNHL can be effectively managed with a fitting hearing aid (HA) by providing sound amplification, and several findings suggest that the HA may also be helpful for people with tinnitus. Nevertheless, in terms of the effects of HA use for residual hearing protection for patients with tinnitus and co-existing hearing loss, inadequate attention is still paid by medical personnel, and relevant evidence remains preliminary at this point in time. To assess the full extent of tinnitus patients, investigators need to carry out a series of tests, including hearing assessment and psychometric tests. Pure tone audiometry (PTA) and otoacoustic emission (OAE) tests are used to calculate the average hearing thresholds and the outer hair cell function, while the Tinnitus hazard Index (THI), the Visual Analogue Scale (VAS), the Hospital Anxiety and the Depression Scale (HADs) and the Athens Insomnia Scale-8 (AIS-8) questionnaires were for patients' psychology status. Investigators hypothesize that in patients with tinnitus and hearing loss, HA intervention results in better conditions of tinnitus and lower hearing threshold reduction. Here investigators planned to enroll patients into two groups, the HA and non-HA (served as the control) intervention patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults aged older than 18 years old and less than 70 years;
- •Chronic (\>6 months) subjective tinnitus, unilateral or bilateral;
- •Diagnosed with a high-frequency SNHL;
- •Be available for six months after starting the study to complete the follow-up questionnaires;
- •Readiness to participate in the study and sign the informed consent.
- •Be covered by public health insurance and eligible for reimbursement.
Exclusion Criteria
- •Objective tinnitus;
- •Conductive HL;
- •Unstable medical history that limits participation;
- •Undergoing any other concurrent treatments on tinnitus or HL;
- •Having used HAs in the past 1 year;
- •Unwilling or unable to use HAs daily;
- •Alcohol or drug abuse;
- •Unable to read or write.
Outcomes
Primary Outcomes
tinnitus handicap inventory (THI)
Time Frame: 6 months from baseline
The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.
Secondary Outcomes
- the Hospital Anxiety and Depression Scale (HADs)(6 months from baseline)
- speech recognition score (SRS) test(6 months from baseline)
- pure tone audiometry (PTA)(6 months from baseline)
- otoacoustic emission (OAE)(6 months from baseline)
- the Athens Insomnia Scale-8 (AIS-8)(6 months from baseline)