Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534130
• Other study ID #: 30801488
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Parasomnias
• Sleep Wake Disorders
• Syndrome

Intervention

Device:
• Acupuncture
Participants will receive five sessions of verum acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.
• Sham acupuncture
Participants will receive five sessions of sham acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.

Locations

Country	Name	City	State
China	Chengdu university of Traditonal Chinese Medcine	Chengdu	Si Chuan Province

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sleep perception	The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.	Change from baseline in sleep perception at 4 weeks
Secondary	The Pittsburgh Sleep Quality Index(PSQI)		Change from baseline in PSQI at 4 weeks
Secondary	The Fatigue Severity Scale(FSS)		Change from baseline in FSS at 4 weeks
Secondary	The Somatic and Psychological Health Report(SPHR)		Change from baseline in SPHR at 4 weeks
Secondary	The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)		Change from baseline in SF-36 at 4 weeks
Secondary	Sleep-wake rhythm		Change from baseline in sleep-wake rhythm at 4 weeks
Secondary	DSWS-REM sleep rhythm		Change from baseline in DSWS-REM sleep rhythm at 4 weeks
Secondary	REM sleep rhythm		Change from baseline in REM sleep rhythm at 4 weeks
Secondary	Sleep latency		Change from baseline in sleep latency at 4 weeks
Secondary	Total sleep time		Change from baseline in total sleep time at 4 weeks
Secondary	Sleep efficiency		Change from baseline in sleep efficiency at 4 weeks
Secondary	Percentage of every sleep stage		Change from baseline in percentage of every sleep stage at 4 weeks