The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders
1 other identifier
interventional
20
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 14, 2025
February 1, 2025
1.9 years
September 17, 2024
February 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective sleep indicators and clinical sleep-related scales
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
From enrollment to the end of treatment at 4 weeks
Study Arms (1)
Intervention Group
EXPERIMENTALtranscranial magnetic stimulation or transcranial direct current stimulation or daytime timed bright light exposure
Interventions
repetitive transcranial magnetic stimulation, or transcranial direct current stimulation, or daytime timed bright light exposure
Eligibility Criteria
You may qualify if:
- \- Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
September 17, 2024
First Posted
January 28, 2025
Study Start
February 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 14, 2025
Record last verified: 2025-02