Electro-acupuncture for treating the treatment-resistant insomnia : randomized controlled, assessor-blinded, pilot clinical trial
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0003235
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. Patients aged 19 years - 80 years
2. Patinets who continous taking medication for improving insomnia symptoms over the last 3 months, and not changed their regular medication type or doseage to improve insomnia within the last 2 weeks
3. Total score in the Insomnia Severity Index (ISI)=15 points
4. fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) diagnostic criteria for insomnia disorder
5. Willingness to participate in the trial and having provided written consent
1. Having undergone Korean medical treatment (eg, acupuncture, moxibustion, cupping, herbal medicine) within last 2 weeks for improving insomnia
2. Initiation the dietary supplement regimen or non-pharmacological therapies (eg, cognitive behavioural therapy, meditation, etc) to alleviate insomnia within the last 2 weeks or plans for initiation during the trial.
3. The patients with unstable(not controlled) schizophrenia, mania, bipolar disorder within last 6 months, or a subscale of either anxiety or depression in Hamilton Anxiety and Depression Scale score =11 points
4. The patients with substance abuse/dependence within last 6 months
5. Having experienced suicide/murder/self-injury attempt
6. Working shifts or changes in day/night work schedule that could impact circadian rhythm
7. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia
8. Taking haemostatic agents (eg, Greenmono, Advate, Monoclate-P, Facnyne, BeneFix) because of cardiovascular or haemostatic disorders
9. Abnormal findings in thyroid function test (abnormal level of free thyroxine (free T4) and thyroid-stimulating hormone (TSH) <0.1 µIU/mL or TSH >5.1 µIU/mL)
10. Inadequate findings in laboratory test(total bilirubin> 2 times compared to the normal upper limit in research institute, ALT(Alanine transaminase) or AST(Aspartate transaminase) > 2.5 times compared to the normal upper limit in research institute, Creatinine > 2.5 times compared to the normal upper limit in research institute, WBC count < 1,500 ? or =10,000 ?, Absolute Neutrophil Count(ANC)< 1,000, platelets count < 75,000/µL, positive in urine HCG, or other abnormal findings that could impact the trial by investigator’s decision)
11. Diagnosed serious chronic disease (e.g. malignant tumor, active pulmonary tuberculosis, chronic liver disease or chronic kidney disease ect.)
12. History of hypersensitivity reactions to acupuncture or inability to cooperate with acupuncture therapy
13. The presence of implants that could interfere with EA or a history of hypersensitivity reactions to electrostimulation
14. Pregnancy, lactation or planning to become pregnant
15. Having participated in other clinical trials within 4 weeks of the beginning of the trial
16. Difficulty complying with the study protocol(treatment, visiting, filling in questionnaries)
17. Subjects who are not appropriate by investigator’s decision
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index (ISI)
- Secondary Outcome Measures
Name Time Method Insomnia Severity Index (ISI);Pittsburgh Sleep Quality Index, PSQI;Sleep Diary;Econimic study assessment (EQ-5D, EQ-VAS, SF-36, cost measurement);Adverse effects;laboratory test;Hospital Anxiety and Depression Scale, Korean ver. HADS;actigraphy;Pattern Identifications for Insomnia;Physical symptoms accompanied with insomnia