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Trial record 4 of 19 for:    Open Studies | "Fatigue Syndrome, Chronic"
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Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

This study is currently recruiting participants.
Verified August 2012 by Chengdu University of Traditional Chinese Medicine
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
History of Changes
  Purpose

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 Intervention
Chronic Fatigue Syndrome
 Device: Acupuncture
Device: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: April 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534130

Contacts
Contact: Xi Wu, A.P. 86-15928830710 wuxi403@hotmail.com

Locations
China, Si chuan Province
Chengdu university of Traditonal Chinese Medcine Recruiting
Chengdu, Si chuan Province, China, 610075
Contact: Xi Wu, A.P.     86-15928830710     wuxi403@hotmail.com    
Principal Investigator: Xiangdong Tang, Professor            
Principal Investigator: Xiaoqin Chen, Physician            
Sub-Investigator: Fei Lei, Housestaff            
Sub-Investigator: Bin Huang, Postgraduate            
Sub-Investigator: Jun Lin, Postgraduate            
Sub-Investigator: Rufei Zhang, Postgraduate            
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
West China Hospital
Investigators
Study Director: Xi Wu, A.P. School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Wu Xi, Principal Investigator, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01534130     History of Changes
Other Study ID Numbers: 30801488
Study First Received: December 14, 2011
Last Updated: August 6, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Chronic Fatigue Syndrome
Sleep Disorder, Adjustment
Acupuncture

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Fatigue
Sleep Disorders
Parasomnias
Signs and Symptoms
Virus Diseases
Muscular Diseases
 Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013