Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
| Tracking Information | |||||
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| First Received Date ICMJE | December 14, 2011 | ||||
| Last Updated Date | August 6, 2012 | ||||
| Start Date ICMJE | April 2011 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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 |
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| Change History | Complete list of historical versions of study NCT01534130 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome | ||||
| Official Title ICMJE | Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Fatigue Syndrome | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 72 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01534130 | ||||
| Other Study ID Numbers ICMJE | 30801488 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wu Xi, Chengdu University of Traditional Chinese Medicine | ||||
| Study Sponsor ICMJE | Chengdu University of Traditional Chinese Medicine | ||||
| Collaborators ICMJE | West China Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Chengdu University of Traditional Chinese Medicine | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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