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

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: 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. Instructional prompts, visual displays, and background audio volume will be dynamically adjusted in real time according to changes in the participant’s meditation‐related EEG brain state, to deliver differentiated audio‐visual feedback stimuli. The daily intervention session shall be completed prior to the participant’s bedtime on each intervention day.;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 during the mindfulness meditation intervention, while instructional prompts will only be delivered before the start of the intervention session. During the intervention process, the visual displays and background audio volume will remain constant, and will not be dynamically adjusted according to changes in the participant’s meditation‐related EEG brain state; 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.; CONDITION: tinnitus PRIMARY OUTCOME: Tinnitus severity; SECONDARY OUTCOME: Anxiety level;Depression level;Sleep quality;The level of attention and awareness in the current experience;Tinnitus loudness; 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.
Epistemonikos ID: 57677e115b88512691b1c81fe4740a5b173393a8
First added on: May 09, 2026