The Effect of Different Sound Stimulation on The Residual Inhibition of Tinnitus

Not Applicable

Recruiting

• Conditions: Tinnitus

• Registration Number: NCT06646302
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study Start: 2024-05-21
• Status Verified: 2024-08
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Subjective tinnitus loudness changes	Immediately after the sound stimulation session.	Compared with the proportion of normal loudness of tinnitus (0 represents no tinnitus, and 1 represents tinnitus at normal loudness).

Secondary Outcome Measures

Name	Time	Method
Recovery time	Immediately after the sound stimulation session.	The time it takes for the loudness of tinnitus to return to its normal level.
Minimum masking level (MML)	Immediately after the sound stimulation session.	The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Tinnitus loudness matching	Immediately after the sound stimulation session.	Used to measure the loudness of tinnitus.
Tinnitus pitch matching	Immediately after the sound stimulation session.	Used to measure the pitch of tinnitus.

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China