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NCT Number: NCT06797284

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

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 .

Recruiting

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Key information

Age range

8 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

00 86 512 67783307

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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).
  • History of severe drug or alcohol abuse within the past year;
  • 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.
  • Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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

Other names: Transcranial Electrical Stimulation, light therapy

Primary outcomes

  1. Objective sleep indicators and clinical sleep-related scales

    Time frame: From enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. Resting-state electroencephalogram, resting-state functional magnetic resonance imaging, blood biochemical indicators

    Time frame: From enrollment to the end of treatment at 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Feng Liu, PhD

CONTACT

[email protected]

+86 512 67783307

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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