Primary insomnia (named as Insomnia Disorder in DSM-V) Mental and Behavioural Disorders Nonorganic insomnia
Conditions
Interventions
The 88 eligible participants will be randomly allocated to two different groups:
Intervention Group: Participants in the intervention group will receive acupuncture therapy three time
Sponsors
Beijing Scientific Committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meeting the primary insomnia criteria of DSM-IV-TR 2. Patients with insomnia persistent for 3 months or longer before the start of the observation period 3. Score of 8 or above on the PSQI, 33 or above on the HAS 4. Having not yet received any psychoactive medications 5. No problem with communication and intelligence 6. Either gender aged 18-65 years 7. Signed the written informed consent form for the clinical trial
Exclusion criteria
Exclusion criteria: 1. Patients who had epilepsy, diabetes mellitus, cardiovascular disease, kidney failure, hypertension, metabolic diseases, benign prostatic hyperplasia 2. Patients who had depression, anxiety ,schizophrenia and other severe mental disorders 3. Patients who had other sleep disorders, or discovered any other sleep disorder on PSG at the baseline, like sleep apnea, restless legs syndrome 4. Pregnancy, breastfeeding, or woman of childbearing age not on a proper method of birth control 5. Patients who had acupuncture for insomnia treatment in the past month 6. Patients who had taken alcohol and/or mentally active drug, drug abuse and dependence 7. Patients who fear or can’t accept the acupuncture therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sleep quality assessment: Pittsburgh Sleep Quality Index (PSQI) 2. Hyperarousal level assessment (HAS) Assessment time of the outcome measures above will be: baseline, 2 and 4 weeks during the treatment, and 8 weeks after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue Scale-14 (FS-14) Assessment time: the baseline, 2 and 4 weeks during the treatment, and 8 weeks after the treatment. 2. Polysomnography (PSG) 3. Heart rate variability (HRV) 4. Morning salivary cortisol level The outcome measures above will be assessed at baseline and the first week after treatment. | — |
Countries
China
Outcome results
None listed