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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05343026
Study type	Interventional
Source	Eye & ENT Hospital of Fudan University
Contact	Sun
Phone	+86-18917786102
Email	sunshine7896@126.com
Status	Not yet recruiting
Phase	N/A
Start date	July 1, 2022
Completion date	December 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04987502` - Virtual Reality and Subjective Tinnitus	N/A
Completed	`NCT04281953` - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting	`NCT04404439` - Treatment of Tinnitus With Migraine Medications	Phase 4
Completed	`NCT03782220` - Effects of Kinesio Taping in Patients With Somatosensory Tinnitus	N/A
Completed	`NCT05711641` - Action of Intra-auricular Topical Lidocaine on Tinnitus	N/A
Completed	`NCT03711630` - Impact of Meditation on Bothersome Tinnitus	N/A
Completed	`NCT05591144` - Short-term Oral Prednisone for Acute Subjective Tinnitus	N/A
Completed	`NCT04565132` - HD-tDCS as a Treatment for Chronic Tinnitus	N/A
Completed	`NCT02315508` - Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo	Phase 2
Active, not recruiting	`NCT03888521` - Evaluating the GN ReSound Relief App Using task-and Rest-based fMRI	N/A
Not yet recruiting	`NCT05507372` - Treatment for Post Acute COVID-19 Syndrome	N/A
Recruiting	`NCT05198973` - Bumblebee Breath Effect on Tinnitus in Older Patients	N/A
Not yet recruiting	`NCT04623957` - Safety and Efficacy of Acupressure Applied Through ForgTin© in Patients With Tinnitus	N/A
Recruiting	`NCT05964725` - The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus	N/A
Not yet recruiting	`NCT05417711` - Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus	N/A
Recruiting	`NCT04162405` - Tinnitus in Patients With and Without Sensorineural Hearing Loss
Completed	`NCT03716544` - Efficacy of Amplification With Hearing Aids for Tinnitus Relief	N/A
Completed	`NCT04127708` - Tinnitus and Acupuncture	N/A
Completed	`NCT03638986` - Comparison of the Two Validated German Versions of the "Tinnitus Functional Index" for Switzerland and for Germany
Not yet recruiting	`NCT06433895` - Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms