Last updated: November 21, 2024
Sponsor: Xijing Hospital
Overall Status: Completed
Phase
N/A
Condition
Anxiety Disorders
Treatment
transcranial magnetic stimulation
Clinical Study ID
NCT05992285
20232190
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- All participants aged from 18 to 60 years old; all participants met diagnosticcriteria for insomnia disorder according to the Diagnostic and Statistical Manual ofMental Disorders-V (DSM-V), and scored >10 on PSQI , ≤14 on the Hamilton AnxietyScale (HAMA), and ≤17 on the Hamilton Depression Scale (HAMD); no sleep-affectingdrugs were taken 1 month before or during the trial (non-prescription sleepmedication, benzodiazepines or hypnotics, ect.); patients can cooperate to completethe treatment and related examination items; all subjects signed informed-consentforms before enrolling in the trial.
Exclusion
Exclusion Criteria:
- The patient is unable to cooperate with the completion of treatment andexaminations; there are other types of sleep disorders; a history of psychotropicdrug or alcohol dependence or abuse in the last 2 years; have undertakentrans-meridian travel across more than two time zones or worked night shifts in thepreceding one month or during the trial period; plan surgical treatment within 1month before or during the trial; evidence of neurological or other physicaldiseases such as respiratory, cardiac, renal, hepatic, endocrinal diseases and otherpsychiatric diseases as assessed by clinical history, physical examination orroutine laboratory tests; pregnancy or breastfeeding women; any contraindication forrTMS (including implanted metal and devices in the body, and history of epilepsy);concurrent other clinical trials; patient or family member withdrawsinformed-consent.
Study Design
Total Participants: 68
Treatment Group(s): 1
Primary Treatment: transcranial magnetic stimulation
Phase:
Study Start date:
August 16, 2023
Estimated Completion Date:
October 29, 2024
Connect with a study center
First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi 710068
ChinaSite Not Available
Xi'an Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi 710021
ChinaSite Not Available
Xi'an International Medical Center Hospital
Xi'an, Shaanxi 710100
ChinaSite Not Available
Xi'an NO.1 Hospital
Xi'an, Shaanxi 710002
ChinaSite Not Available
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi 710032
ChinaSite Not Available

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