Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss
Primary Purpose
Tinnitus, Subjective, Hearing Loss, High-Frequency
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aids
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HA treatment group
non-HA treatment group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
tinnitus handicap inventory (THI)
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.
tinnitus handicap inventory (THI)
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
speech recognition score (SRS) test
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.
speech recognition score (SRS) test
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)
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
pure tone audiometry (PTA)
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
otoacoustic emission (OAE)
OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
otoacoustic emission (OAE)
OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
the Hospital Anxiety and Depression Scale (HADs)
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).
the Hospital Anxiety and Depression Scale (HADs)
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).
the Athens Insomnia Scale-8 (AIS-8)
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).
the Athens Insomnia Scale-8 (AIS-8)
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).
Full Information
NCT ID
NCT05343026
First Posted
April 18, 2022
Last Updated
April 21, 2022
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05343026
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Hearing Loss, High-Frequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HA treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-HA treatment group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing aids
Intervention Description
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.
Primary Outcome Measure Information:
Title
tinnitus handicap inventory (THI)
Description
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.
Time Frame
3 months from baseline
Title
tinnitus handicap inventory (THI)
Description
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.
Time Frame
6 months from baseline
Secondary Outcome Measure Information:
Title
speech recognition score (SRS) test
Description
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.
Time Frame
3 months from baseline
Title
speech recognition score (SRS) test
Description
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.
Time Frame
6 months from baseline
Title
pure tone audiometry (PTA)
Description
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
Time Frame
3 months from baseline
Title
pure tone audiometry (PTA)
Description
PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level.
Time Frame
6 months from baseline
Title
otoacoustic emission (OAE)
Description
OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
Time Frame
3 months from baseline
Title
otoacoustic emission (OAE)
Description
OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged.
Time Frame
6 months from baseline
Title
the Hospital Anxiety and Depression Scale (HADs)
Description
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).
Time Frame
3 months from baseline
Title
the Hospital Anxiety and Depression Scale (HADs)
Description
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).
Time Frame
6 months from baseline
Title
the Athens Insomnia Scale-8 (AIS-8)
Description
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).
Time Frame
3 months from baseline
Title
the Athens Insomnia Scale-8 (AIS-8)
Description
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).
Time Frame
6 months from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun
Phone
+86-18917786102
Email
sunshine7896@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peifan Li
Phone
+86-18373151369
Email
20211260020@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan Sun
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss
We'll reach out to this number within 24 hrs