Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Not Applicable

Completed

• Conditions: Chronic Fatigue Syndrome
• Interventions: Device: Acupuncture; Device: Sham acupuncture

• Registration Number: NCT01534130
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

The investigators will conduct acupuncture for participants with chronic fatigue syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the fatigue, reducing accompanying symptoms and for improving the life quality of CFS.

Detailed Description

This trial is a randomized, placebo controlled clinical trial. 72 participants with CFS are randomly allocated to two different groups. Treatment group is acupuncture, while the control group is sham acupuncture. The ratio of treatment group and control group is 2:1. Both acupuncture and sham acupuncture group will receive 12 sessions of verum/sham acupuncture in 4 weeks.

The result of this trial (available in 2011) will supply evidence on the efficacy of acupuncture for sleep disorder of CFS.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Participants who meet the diagnosis criteria of CFS;
2. Clinically evaluated, exclude any disease that can explain the chronic fatigue;
3. The onset age of CFS is between 18 and 50 years old;
4. Have not taken any hypnotic, melatonin, or antidepressants within 45 days;
5. Willing to finish the whole observation period;
6. With written consent form signed by themselves.

Exclusion Criteria

1. Chronic fatigue caused by diseases such as internal diseases(for example, pulmonary emphysema, rheumatoid arthritis, etc.), mental illness(for example, any type of dementia paranoids, depression, etc.), some diseases that just onset or evaluated (for example, sleep deprivation, untreated diabetes, etc.), some diseases that need recovery gradually(for example, restless legs syndrome, lactation, etc.), morbid obesity;
2. Participants in other clinical research;
3. Pregnant women, lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	Acupuncture	-
sham acupuncture	Sham acupuncture	-

Primary Outcome Measures

Name	Time	Method
The sleep perception	Change from baseline in sleep perception at 4 weeks	The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.

Secondary Outcome Measures

Name	Time	Method
The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)	Change from baseline in SF-36 at 4 weeks
The Somatic and Psychological Health Report(SPHR)	Change from baseline in SPHR at 4 weeks
DSWS-REM sleep rhythm	Change from baseline in DSWS-REM sleep rhythm at 4 weeks
Sleep efficiency	Change from baseline in sleep efficiency at 4 weeks
The Fatigue Severity Scale(FSS)	Change from baseline in FSS at 4 weeks
Sleep-wake rhythm	Change from baseline in sleep-wake rhythm at 4 weeks
REM sleep rhythm	Change from baseline in REM sleep rhythm at 4 weeks
Total sleep time	Change from baseline in total sleep time at 4 weeks
The Pittsburgh Sleep Quality Index(PSQI)	Change from baseline in PSQI at 4 weeks
Sleep latency	Change from baseline in sleep latency at 4 weeks
Percentage of every sleep stage	Change from baseline in percentage of every sleep stage at 4 weeks

Trial Locations

Locations (1)

Chengdu university of Traditonal Chinese Medcine; 🇨🇳 Chengdu, Si Chuan Province, China