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

April 21, 2022 updated by: Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tinnitus handicap inventory (THI)
Time Frame: 3 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.
3 months from baseline
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.
6 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech recognition score (SRS) test
Time Frame: 3 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.
3 months from baseline
speech recognition score (SRS) test
Time Frame: 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.
6 months from baseline
pure tone audiometry (PTA)
Time Frame: 3 months from baseline
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
3 months from baseline
pure tone audiometry (PTA)
Time Frame: 6 months from baseline
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
6 months from baseline
otoacoustic emission (OAE)
Time Frame: 3 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.
3 months from baseline
otoacoustic emission (OAE)
Time Frame: 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.
6 months from baseline
the Hospital Anxiety and Depression Scale (HADs)
Time Frame: 3 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).
3 months from baseline
the Hospital Anxiety and Depression Scale (HADs)
Time Frame: 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).
6 months from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time Frame: 3 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).
3 months from baseline
the Athens Insomnia Scale-8 (AIS-8)
Time Frame: 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).
6 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Shan Sun, Eye and ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shan Sun

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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