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

Not Applicable

• Conditions: Tinnitus, Subjective; Hearing Loss, High-Frequency
• Interventions: Device: Hearing aids

• Registration Number: NCT05343026
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-25
• Last Update Posted: 2022-04-25
• Study Start: 2022-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA treatment group	Hearing aids	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.

Primary Outcome Measures

Name	Time	Method
tinnitus handicap inventory (THI)	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 Outcome Measures

Name	Time	Method
the Hospital Anxiety and Depression Scale (HADs)	6 months from baseline	The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21).
speech recognition score (SRS) test	6 months from baseline	The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition.
pure tone audiometry (PTA)	6 months from baseline	PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
otoacoustic emission (OAE)	6 months from baseline	OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
the Athens Insomnia Scale-8 (AIS-8)	6 months from baseline	The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).