A study on the evaluation of changes in brain activation and autonomic nervous system through transcutaneous electric nerve stimulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011886

Enrollment

200

Registered

2026-04-21

Start date

2023-07-01

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

None listed

Interventions

Medical Device : The intervention in this study aims to evaluate the effects of transcutaneous cervical vagus nerve stimulation (tc-VNS) on sleep and brain functional connectivity. Participants will v

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. No current use of medication at the time of enrollment 2. No history of neurological or psychiatric disorders 3. Subthreshold insomnia defined as an Insomnia Severity Index (ISI) score of =8 4. Provision of written informed consent prior to participation

Exclusion criteria

Exclusion criteria: 1. Current use of any medication at the time of enrollment 2. History of neurological or psychiatric disorders 3. ISI score below 8 (not meeting subthreshold insomnia criteria) 4. Scalp or skin conditions that may interfere with EEG recording 5. Inability to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Longitudinal changes in EEG- and ECG-based biosignal measures — frequency band-specific power and functional connectivity derived from resting-state EEG, and autonomic nervous system indices based on ECG (heart rate variability, HRV)	—

Secondary

Measure	Time frame
Pittsburgh Sleep Quality Index (PSQI) global score;Insomnia Severity Index (ISI) total score	—

Countries

Korea, Republic of

Contacts

Public ContactYunjeong Choi

Korea University

chldbswjd25@korea.ac.kr+82-2-3290-4939

Outcome results