Primary insomnia Nervous System Diseases Sleep disorders
Conditions
Interventions
This is a six-week, single-blind, randomised, sham-controlled study. A total of 150 untreated patients with primary insomnia will be recruited. Under single-blind conditions, patients will be randomly
Sponsors
Beijing Hospital of Traditional Chinese Medicine (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Either gender aged 25 - 75 years 2. Have primary insomnia diagnosed from International Classification of Diseases, 10th Edition (ICD-10) 3. Patients with insomnia persistent for 4 weeks or longer before the start of observation period 4. Have not yet received any psychoactive medications 5. Patients who submit written informed consent for study entry 6. Able to take part in the entire treatment and data collection procedure
Exclusion criteria
Exclusion criteria: 1. Diagnosis of depression, anxiety or schizophrenia 2. Diagnosis of serious disease of heart, brain, kidney or liver 3. History of sleep apnoea (temporary cessation of breathing during sleep) 4. Suffering from insomnia less than 4 weeks 5. Treatment with investigational drugs in past six months 6. Ever received acupuncture against insomnia, or during the last year received acupuncture for any indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sleepiness measured using the Epworth Sleepiness Scale. Assessments will be conducted at baseline and at day 7, 14, 28, 42 and 2 months follow-up. 2. Sleep diary assessments will be conducted every day until 2 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in the Pittsburgh Sleep Quality Index (PSQI). Assessments will be conducted at baseline and at day 28, 42 and 2 months follow-up. 2. Changes in the 36-item Short Form Health Survey (SF-36) scores. Assessments will be conducted at baseline and at day 28, 42 and 2 months follow-up. | — |
Countries
China
Outcome results
None listed