Clinical trial NCT05343026: Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Hearing Loss, High-Frequency
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged older than 18 years old and less than 70 years;
2. Chronic (\>6 months) subjective tinnitus, unilateral or bilateral;
3. Diagnosed with a high-frequency SNHL;
4. Be available for six months after starting the study to complete the follow-up questionnaires;
5. Readiness to participate in the study and sign the informed consent.
6. Be covered by public health insurance and eligible for reimbursement.

Exclusion Criteria:

1. Objective tinnitus;
2. Conductive HL;
3. Unstable medical history that limits participation;
4. Undergoing any other concurrent treatments on tinnitus or HL;
5. Having used HAs in the past 1 year;
6. Unwilling or unable to use HAs daily;
7. Alcohol or drug abuse;
8. Unable to read or write.

Primary outcomes:
measure: tinnitus handicap inventory (THI)
timeFrame: 3 months from baseline
measure: tinnitus handicap inventory (THI)
timeFrame: 6 months from baseline
Secondary outcomes:
measure: speech recognition score (SRS) test
timeFrame: 3 months from baseline
measure: speech recognition score (SRS) test
timeFrame: 6 months from baseline
measure: pure tone audiometry (PTA)
timeFrame: 3 months from baseline
measure: pure tone audiometry (PTA)
timeFrame: 6 months from baseline
measure: otoacoustic emission (OAE)
timeFrame: 3 months from baseline
measure: otoacoustic emission (OAE)
timeFrame: 6 months from baseline
measure: the Hospital Anxiety and Depression Scale (HADs)
timeFrame: 3 months from baseline
measure: the Hospital Anxiety and Depression Scale (HADs)
timeFrame: 6 months from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: 3 months from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: 6 months from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Shan Sun
role: PRINCIPAL_INVESTIGATOR
References: