Acupuncture for treatment of primary insomnia

Not Applicable

Completed

• Conditions: Primary insomnia (named as Insomnia Disorder in DSM-V); Mental and Behavioural Disorders; Nonorganic insomnia

• Registration Number: ISRCTN16079489
• Lead Sponsor: Beijing Scientific Committee

Brief Summary

2016 protocol in https://pubmed.ncbi.nlm.nih.gov/26956161/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-07
• Study Completion: 2017-06-30
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Sleep quality assessment: Pittsburgh Sleep Quality Index (PSQI)<br> 2. Hyperarousal level assessment (HAS)<br> Assessment time of the outcome measures above will be: baseline, 2 and 4 weeks during the treatment, and 8 weeks after the treatment.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Fatigue Scale-14 (FS-14)<br> Assessment time: the baseline, 2 and 4 weeks during the treatment, and 8 weeks after the treatment.<br> 2. Polysomnography (PSG)<br> 3. Heart rate variability (HRV)<br> 4. Morning salivary cortisol level<br> The outcome measures above will be assessed at baseline and the first week after treatment.<br>