Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Sponsor

Chengdu University of Traditional Chinese Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01534130

Collaborator

West China Hospital (Other)

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Device: Acupuncture Device: Sham acupuncture	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Actual Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acupuncture	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. Other Names: Streitberger needles(Special No.16)
Sham Comparator: sham acupuncture	Device: 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. Other Names: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).

Arm

Intervention/Treatment

Experimental: acupuncture

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.

Other Names:

Streitberger needles(Special No.16)

Sham Comparator: sham acupuncture

Device: 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.

Other Names:

Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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;
Participants in other clinical research;
Pregnant women, lactating women.