Chronic Insomnia
Conditions
Interventions
Healthy control:none
Experimental group 1:rTMS by figure-of-eight coil
Experimental group 2:rTMS by double-cone coil
Sponsors
Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Chronic insomnia patient inclusion criteria: 1) meats the clinical diagnostic criteria for primary chronic insomnia in DSM-5 criteria); 2) PSQI=5, ISI=8; 3) complain of impaired daytime functioning (=2 on component 5 and/or =2 on component 7 of the Chinese version of the Pittsburgh Sleep Quality Index [PSQI]); 4) aged 18-65 years, gender unlimited; 5) without anxiety (HAMA <= 14, excluding item 4) or depression (HAMD-24 < 20, excluding items 4-6); 6) is willing to discontinue their sleep medication for a period of 2 weeks (washout period) prior to enrolling in the study or not taking any treatment for insomnia for at least 2 weeks before the baseline visit. Healthy control inclusion criteria: 1) a total score <5 on the PSQI and a total score = 8 on the ISI; 2) aged 18–65 years; 3) without frequent jet lag or not doing night shift work; 4) right-handed; 5) no symptoms or history of psychiatric disorders
Exclusion criteria
Exclusion criteria: Chronic insomnia patient exclusion criteria: 1) presence of other sleep disorders including sleep apnea, periodic limb movements, parasomnias, hypersomnia, or participation in concurrent clinical trials; 2) with frequent jet lag or doing night shift work; 3) previous diagnosis of neurological and mental diseases (such as Parkinson's disease and depression); 4) Epworth Sleepiness Scale (ESS) >11; 5) being pregnant or lactating, or plans to become pregnant during the study period; 6); current smoking of more than 10 cigarettes per day, consumption of alcohol (no more than 2 standard alcoholic drinks per day for a period> 1 month in the preceding year), caffeinated beverage/pill consumption was estimated to contain more than 300 mg of caffeine daily (approximately 3 standard cups of coffee); 7) Contraindications for MRI /rTMS (e.g. having a cochlear implant, a cardiac pacemaker, an implanted device (i.e., deep brain stimulation), or metal in the brain). Healthy control exclusion criteria: Contraindications for MRI /rTMS; psychiatric disorders (HAMD-24=8, HAMA=6); pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index(PSQI);Insomnia Severity Index (ISI);Self-rating depression scale (SDS);Stroop test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale (HAMA);Hamilton Depression Scale (HAMD);Self-Rating Anxiety Scale(SAS);Montreal Cognitive Assessment (MoCA) Beijing version;Color Trails Test (CTT);Digital Span Test (DST);Symbol Digit Modalities Testt (DSST); | — |
Countries
China
Contacts
Public ContactXiquan Hu
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed