The effect of acupuncture compared with sham acupuncture and estazolam in primary insomnia
- Conditions
- Primary insomniaNervous System DiseasesSleep disorders
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>2. Sleep diary assessments will be conducted every day until 2 months follow-up
- Secondary Outcome Measures
Name Time Method 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. <br>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.