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Completed

NCT Number: NCT01534130

Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu university of Traditonal Chinese Medcine

Chengdu, Sichuan, 610075, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture

Device

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 acupuncture

Device

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).

Primary outcomes

  1. The sleep perception

    Time frame: 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 outcomes

  1. The Pittsburgh Sleep Quality Index(PSQI)

    Time frame: Change from baseline in PSQI at 4 weeks

  2. The Fatigue Severity Scale(FSS)

    Time frame: Change from baseline in FSS at 4 weeks

  3. The Somatic and Psychological Health Report(SPHR)

    Time frame: Change from baseline in SPHR at 4 weeks

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

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

  5. Sleep-wake rhythm

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

  6. DSWS-REM sleep rhythm

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

  7. REM sleep rhythm

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

  8. Sleep latency

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

  9. Total sleep time

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

  10. Sleep efficiency

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

  11. Percentage of every sleep stage

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

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • West China Hospital

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 16, 2012
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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