Clinical trial NCT01534130: Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
Official title: Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic Fatigue Syndrome
Sleep Disorder, Adjustment
Acupuncture
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2012-02-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The sleep perception
timeFrame: Change from baseline in sleep perception at 4 weeks
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Change from baseline in PSQI at 4 weeks
measure: The Fatigue Severity Scale(FSS)
timeFrame: Change from baseline in FSS at 4 weeks
measure: The Somatic and Psychological Health Report(SPHR)
timeFrame: Change from baseline in SPHR at 4 weeks
measure: The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)
timeFrame: Change from baseline in SF-36 at 4 weeks
measure: Sleep-wake rhythm
timeFrame: Change from baseline in sleep-wake rhythm at 4 weeks
measure: DSWS-REM sleep rhythm
timeFrame: Change from baseline in DSWS-REM sleep rhythm at 4 weeks
measure: REM sleep rhythm
timeFrame: Change from baseline in REM sleep rhythm at 4 weeks
measure: Sleep latency
timeFrame: Change from baseline in sleep latency at 4 weeks
measure: Total sleep time
timeFrame: Change from baseline in total sleep time at 4 weeks
measure: Sleep efficiency
timeFrame: Change from baseline in sleep efficiency at 4 weeks
measure: Percentage of every sleep stage
timeFrame: Change from baseline in percentage of every sleep stage at 4 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu university of Traditonal Chinese Medcine
state: Si Chuan Province
Study officials:
affiliation: School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine
name: Xi Wu, A.P.
role: STUDY_DIRECTOR
References: