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A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Brain-Computer Interface-Based Mindfulness Meditation on Clinical Symptoms in Patients with Chronic Tinnitus

A Study on Brain-Computer Interface (BCI)-Based Mindfulness Meditation for the Intervention and Alleviation of Tinnitus Symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123258
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tinnitus

Interventions

BCI Feedback Mindfulness Meditation Group:A single-channel Brain-Computer Interface (BCI) system is used to acquire the EEG brain state of participants during the mindfulness meditation intervention.
Standalone Mindfulness Meditation Group:For the standalone mindfulness meditation intervention arm, a single-channel headband will be simultaneously used to record participants’ EEG brain states durin
no audio-visual feedback stimuli will be provided throughout the intervention. The daily intervention session shall be completed prior to the participant’s bedtime on each intervention day.

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. With tinnitus as the primary clinical chief complaint; 2. Self-reported continuous tinnitus that has lasted for 3 months or longer; 3. Aged between 18 and 60 years (inclusive of the 18-year-old lower limit, exclusive of the 60-year-old upper limit); 4. Possess the functional ability to use and operate routine electronic devices independently.

Exclusion criteria

Exclusion criteria: 1. Exclude patients with conductive hearing loss, a history of middle ear surgery, pulsatile tinnitus caused by vascular malformations, and tinnitus from Ménière's disease; 2. Exclude those with a history of head trauma, central nervous system diseases, psychiatric disorders, or drug abuse; 3. Exclude severe hearing loss and other psychiatric disorders such as severe depression or schizophrenia; 4. Exclude tumors and other otological diseases such as vertigo; 5. Exclude those simultaneously participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Tinnitus severity;

Secondary

MeasureTime frame
Anxiety level;Depression level;Sleep quality;The level of attention and awareness in the current experience;Tinnitus loudness;

Countries

China

Contacts

Public ContactZeng Xiangli

The Third Affiliated Hospital of Sun Yat-sen University

zxiangl@mail.sysu.edu.cn+86 20 8217 9215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026