Clinical trial NCT06646302: The Effect of Different Sound Stimulation on The Residual Inhibition of Tinnitus
Official title: The Effect of Different Sound Stimulation on The Residual Inhibition of Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
residual inhibition
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of different sound stimulation on the residual inhibition of tinnitus. In this study, tinnitus patients will be assigned to a cross-over intervention of tinnitus frequency-centered narrowband noise stimulation and low frequency burst sound stimulation.

Detailed description: Residual inhibition (RI) is a common phenomenon of short-term suppression of tinnitus, which refers to the suppression or reduction of tinnitus even after the end of the masking sound. RI is instructive in selecting tinnitus patients suitable for sound therapy. However, the effect of different sound stimulation on the RI of tinnitus remains unclear.

In this study, we hypothesized that low frequency burst sound stimulation is superior to tinnitus frequency-centered narrowband noise stimulation for tinnitus relief, as measured by subjective tinnitus loudness changes. Meanwhile, the neurophysiological mechanisms were further explored by EEG and fNIRS.

Eligibility criteria: Inclusion Criteria:

1. Adults aged between 18 and 70 years old.
2. Subjective tinnitus.
3. Unilateral tinnitus or bilateral tinnitus of the same pitch.
4. Can communicate in Mandarin or with the help of an agent.
5. 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
6. Subjects or their legal representatives can understand the purpose of the study, voluntarily participate and can cooperate in completing the experiment according to the instructions, and sign the informed consent form.

Exclusion Criteria:

1. Vascular pulsatile tinnitus or objective tinnitus.
2. Bilateral tinnitus with different tones.
3. Patients with significant health problems that interfere with or prevent participation in the experiment or cooperation with follow-up visits.
4. Patients with severe auditory hypersensitivity and psychiatric disorders such as severe anxiety and depression;
5. Currently participating in other research programs that may affect tinnitus.
6. Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Primary outcomes:
measure: Subjective tinnitus loudness changes
timeFrame: Immediately after the sound stimulation session.
Secondary outcomes:
measure: Recovery time
timeFrame: Immediately after the sound stimulation session.
measure: Minimum masking level (MML)
timeFrame: Immediately after the sound stimulation session.
measure: Tinnitus loudness matching
timeFrame: Immediately after the sound stimulation session.
measure: Tinnitus pitch matching
timeFrame: Immediately after the sound stimulation session.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Huawei Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: