Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Wu Xi, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01534130
First received: December 14, 2011
Last updated: August 6, 2012
Last verified: August 2012

December 14, 2011
August 6, 2012
April 2011
August 2012   (final data collection date for primary outcome measure)
The sleep perception [ Time Frame: Change from baseline in sleep perception at 4 weeks ] [ Designated as safety issue: Yes ]
The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.
The sleep perception [ Time Frame: Change from baseline in sleep perception at 4 weeks ] [ Designated as safety issue: Yes ]
The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG
Complete list of historical versions of study NCT01534130 on ClinicalTrials.gov Archive Site
  • The Pittsburgh Sleep Quality Index(PSQI) [ Time Frame: Change from baseline in PSQI at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Fatigue Severity Scale(FSS) [ Time Frame: Change from baseline in FSS at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Somatic and Psychological Health Report(SPHR) [ Time Frame: Change from baseline in SPHR at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36) [ Time Frame: Change from baseline in SF-36 at 4 weeks ] [ Designated as safety issue: Yes ]
  • Sleep-wake rhythm [ Time Frame: Change from baseline in sleep-wake rhythm at 4 weeks ] [ Designated as safety issue: Yes ]
  • DSWS-REM sleep rhythm [ Time Frame: Change from baseline in DSWS-REM sleep rhythm at 4 weeks ] [ Designated as safety issue: Yes ]
  • REM sleep rhythm [ Time Frame: Change from baseline in REM sleep rhythm at 4 weeks ] [ Designated as safety issue: Yes ]
  • Sleep latency [ Time Frame: Change from baseline in sleep latency at 4 weeks ] [ Designated as safety issue: Yes ]
  • Total sleep time [ Time Frame: Change from baseline in total sleep time at 4 weeks ] [ Designated as safety issue: Yes ]
  • Sleep efficiency [ Time Frame: Change from baseline in sleep efficiency at 4 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of every sleep stage [ Time Frame: Change from baseline in percentage of every sleep stage at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Pittsburgh Sleep Quality Index [ Time Frame: Change from baseline in PSQ at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Fatigue Severity Scale [ Time Frame: Change from baseline in FSS at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Somatic and Psychological Health Report [ Time Frame: Change from baseline in SPHR at 4 weeks ] [ Designated as safety issue: Yes ]
  • The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire [ Time Frame: Change from baseline in SF-36 at 4 weeks ] [ Designated as safety issue: Yes ]
  • Sleep-wake rhythm [ Time Frame: Change from baseline in sleep-wake rhythm at 4 weeks ] [ Designated as safety issue: Yes ]
  • DSWS-REM rhythm [ Time Frame: Change from baseline in DSWS-REM rhythm at 4 weeks ] [ Designated as safety issue: Yes ]
  • REM rhythm [ Time Frame: Change from baseline in REM rhythm at 4 weeks ] [ Designated as safety issue: Yes ]
  • Sleep latency [ Time Frame: Change from baseline in sleep latency at 4 weeks ] [ Designated as safety issue: Yes ]
  • Total sleep time [ Time Frame: Change from baseline in total sleep time at 4 weeks ] [ Designated as safety issue: Yes ]
  • Sleep efficiency [ Time Frame: Change from baseline in sleep efficiency at 4 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of every sleep stage [ Time Frame: Change from baseline in percentage of every sleep stage at 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Fatigue Syndrome
  • 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 Name: Streitberger needles(Special No.16)
  • 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 Name: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).
  • Experimental: acupuncture
    Intervention: Device: Acupuncture
  • Sham Comparator: sham acupuncture
    Intervention: Device: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact: Xi Wu, A.P. 86-15928830710 wuxi403@hotmail.com
China
 
NCT01534130
30801488
No
Wu Xi, Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
West China Hospital
Study Director: Xi Wu, A.P. School of Acupuncture& Tuina,Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP