The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders

NCT ID: NCT06797284

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-12-31

Brief Summary

Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical/magnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .

Conditions

Insomnia Chronic; Narcolepsy; REM Sleep Behavior Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

transcranial magnetic stimulation or transcranial direct current stimulation or daytime timed bright light exposure

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

repetitive transcranial magnetic stimulation, or transcranial direct current stimulation, or daytime timed bright light exposure

Interventions

Transcranial Magnetic Stimulation

repetitive transcranial magnetic stimulation, or transcranial direct current stimulation, or daytime timed bright light exposure

Intervention Type: DEVICE

Other Intervention Names

Transcranial Electrical Stimulation; light therapy

Eligibility Criteria

Inclusion Criteria

• Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.

Exclusion Criteria

1. Patients with major neurological diseases such as multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.

2. A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).

3. History of severe drug or alcohol abuse within the past year;

4. Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.

5. Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Chun-Feng Liu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chun-Feng Liu, PhD

Role: CONTACT

liuchunfeng@suda.edu.cn

+86 512 67783307

Facility Contacts

Chun-Feng Liu, Ph.D, M.D.

Role: primary

liuchunfeng@suda.edu.cn

00 86 512 67783307

Other Identifiers

LK2024002

Identifier Type: -

Identifier Source: org_study_id