Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss
1 other identifier
interventional
62
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 25, 2022
April 1, 2022
1 year
April 18, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (10)
speech recognition score (SRS) test
3 months from baseline
speech recognition score (SRS) test
6 months from baseline
pure tone audiometry (PTA)
3 months from baseline
pure tone audiometry (PTA)
6 months from baseline
otoacoustic emission (OAE)
3 months from baseline
- +5 more secondary outcomes
Study Arms (2)
HA treatment group
EXPERIMENTALParticipants 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
NO INTERVENTIONNon-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 36575531DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shan Sun
Eye and ENT Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2022
First Posted
April 25, 2022
Study Start
July 1, 2022
Primary Completion
July 1, 2023
Study Completion
December 1, 2023
Last Updated
April 25, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share