Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss

NCT ID: NCT05343026

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-12-01

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.

Conditions

Tinnitus, Subjective; Hearing Loss, High-Frequency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HA treatment group

Participants in the treatment group are required to wear the HAs for at least 3 hours per day, with 24 days per month. Additionally, they will receive regular counseling and lifestyle education from their physicians.

Group Type: EXPERIMENTAL

Hearing aids

Intervention Type: DEVICE

As for screening the hearing and tinnitus testing, the measure typically comprises PTA, SRS, DPOAE, and several widely accepted standardized tinnitus questionnaires, including the THI for tinnitus severity and VAS for tinnitus loudness.

non-HA treatment group

Non-HA treatment group is a waiting list control group (WLC) in which participants will receive the intervention after the waiting period has passed. They will only receive regular counseling and lifestyle education from their physicians in this waiting period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hearing aids

As for screening the hearing and tinnitus testing, the measure typically comprises PTA, SRS, DPOAE, and several widely accepted standardized tinnitus questionnaires, including the THI for tinnitus severity and VAS for tinnitus loudness.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shan Sun

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Central Contacts

Sun

Role: CONTACT

sunshine7896@126.com

+86-18917786102

Peifan Li

Role: CONTACT

20211260020@fudan.edu.cn

+86-18373151369

References

Li P, Tang D, Wu Y, Yin Y, Sun S. Efficacy of hearing aid treatment on sound perception and residual hearing preservation in patients with tinnitus and coexisting hearing loss: study protocol for a randomized controlled trial. Trials. 2022 Dec 27;23(1):1049. doi: 10.1186/s13063-022-07014-0.

Reference Type: DERIVED

PMID: 36575531 (View on PubMed)

Other Identifiers

Shan Sun

Identifier Type: -

Identifier Source: org_study_id