Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Chengdu University of Traditional Chinese Medicine72 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Fatigue Syndrome

Interventions

AcupunctureDEVICE

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 acupunctureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline in sleep perception at 4 weeks

Secondary Outcomes

The Pittsburgh Sleep Quality Index(PSQI)

Time frame: Change from baseline in PSQI at 4 weeks

The Fatigue Severity Scale(FSS)

Time frame: Change from baseline in FSS at 4 weeks

The Somatic and Psychological Health Report(SPHR)

Time frame: Change from baseline in SPHR at 4 weeks

The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)

Time frame: Change from baseline in SF-36 at 4 weeks

Sleep-wake rhythm

Time frame: Change from baseline in sleep-wake rhythm at 4 weeks

DSWS-REM sleep rhythm

Time frame: Change from baseline in DSWS-REM sleep rhythm at 4 weeks

REM sleep rhythm

Time frame: Change from baseline in REM sleep rhythm at 4 weeks

Sleep latency

Time frame: Change from baseline in sleep latency at 4 weeks

Total sleep time

Time frame: Change from baseline in total sleep time at 4 weeks

Sleep efficiency

Time frame: Change from baseline in sleep efficiency at 4 weeks

Percentage of every sleep stage

Time frame: Change from baseline in percentage of every sleep stage at 4 weeks