A study of acupuncturing Chou’s Tiaoshen” acupoints on patients in subacute insomnia

Not Applicable

Completed

• Conditions: Subacute insomnia; Mental and Behavioural Disorders; Insomnia

• Registration Number: ISRCTN24323119
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-13
• Study Completion: 2019-03-30
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. According to the Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5th ed (DSM-V) and Chinese Adult Insomnia Diagnosis and Treatment Guide 2012
2. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
2.1. Difficulty initiating sleep
2.2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings
2.3. Early-morning awakening with inability to return to sleep
3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning
4. The sleep difficulty occurs at least 3 nights per week. The sleep difficulty is present for at least 1 months
5. Experienced insomnia between 4 weeks and 3 months before the start of project
6. Age: patients between 20 and 60 years old
7. Not yet taken estazolam for more than 3 days
8. Patients who agreed to participant in this trial and assigned the informed consent

Exclusion Criteria

1. Having depression, anxiety or schizophrenia
2. Patients with serious heart, liver, kidney and hematopoietic system diseases or mental disorders
3. Patients who could not cooperate with the investigators
4. Insomnia course less than 4 weeks
5.Taken anti-anxiety depression drugs or assisted sleeping medication in the past 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality and disturbances are measured using the Pittsburgh sleep quality index (PSQI) at baseline, day 14 and day 28.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Insomnia severity level are measured using insomnia severity index (ISI) at baseline, day 14 and day 28<br> 2. Daytime function or daytime fatigue is measured using Fatigue Scale (FS)(FS incluing the items of physical fatigue and mental fatigue) at baseline, day 14 and day 28<br> 3. Symptoms of insomnia are measured using Sleep diaries. It will be recorded everyday after patients start to be treated, and we will take their Sleep diaries at day 14 and day 28<br>