ClinicalTrials.gg
RecruitingNCT06797284Updated Feb 14, 2025

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

An interventional study of Transcranial Magnetic Stimulation in Insomnia Chronic, Narcolepsy and REM Sleep Behavior Disorder, sponsored by Second Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 8 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Second Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
8 Years to 75 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Insomnia Chronic
  • Narcolepsy
  • REM Sleep Behavior Disorder
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 20 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention Group

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

    Device: Transcranial Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

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

    Also known as: Transcranial Electrical Stimulation, light therapy

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06797284
Lead sponsor
Second Affiliated Hospital of Soochow University
Responsible party
Chun-Feng Liu (professor, Second Affiliated Hospital of Soochow University) — Principal investigator
First posted
Jan 28, 2025
Start date
Feb 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 14, 2025

Study contacts

Chun-Feng Liu, PhD
Contact
liuchunfeng@suda.edu.cn
+86 512 67783307

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion