Tinnitus, Subjective Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | December 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Eye & ENT Hospital of Fudan University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months from baseline | |
Primary | 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. | 6 months from baseline | |
Secondary | 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. | 3 months from baseline | |
Secondary | 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. | 6 months from baseline | |
Secondary | pure tone audiometry (PTA) | PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level. | 3 months from baseline | |
Secondary | pure tone audiometry (PTA) | PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level. | 6 months from baseline | |
Secondary | 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. | 3 months from baseline | |
Secondary | 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. | 6 months from baseline | |
Secondary | 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). | 3 months from baseline | |
Secondary | 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). | 6 months from baseline | |
Secondary | 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). | 3 months from baseline | |
Secondary | 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). | 6 months from baseline |
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