Chronic Fatigue SyndromeNCT01534130
Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
A study testing Acupuncture in people with Chronic Fatigue Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu university of Traditonal Chinese Medcine
Chengdu, Sichuan, 610075
About this study
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Chronic Fatigue Syndrome, Sleep Disorder, Adjustment, Acupuncture
- Medical subject headings
- Fatigue Syndrome, Chronic, Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Also called Streitberger needles(Special No.16)
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.
Sham acupunctureDevice
Also called Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).
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.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | Not described Receives: Device: Acupuncture |
| sham acupuncture | Sham comparator | Not described Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sleep perception
The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.
Measured: Change from baseline in sleep perception at 4 weeks
Secondary outcomes (11)
The Pittsburgh Sleep Quality Index(PSQI)
Measured: Change from baseline in PSQI at 4 weeks
The Fatigue Severity Scale(FSS)
Measured: Change from baseline in FSS at 4 weeks
The Somatic and Psychological Health Report(SPHR)
Measured: Change from baseline in SPHR at 4 weeks
The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)
Measured: Change from baseline in SF-36 at 4 weeks
Sleep-wake rhythm
Measured: Change from baseline in sleep-wake rhythm at 4 weeks
DSWS-REM sleep rhythm
Measured: Change from baseline in DSWS-REM sleep rhythm at 4 weeks
REM sleep rhythm
Measured: Change from baseline in REM sleep rhythm at 4 weeks
Sleep latency
Measured: Change from baseline in sleep latency at 4 weeks
Total sleep time
Measured: Change from baseline in total sleep time at 4 weeks
Sleep efficiency
Measured: Change from baseline in sleep efficiency at 4 weeks
Percentage of every sleep stage
Measured: Change from baseline in percentage of every sleep stage at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, Li ying, Chengdu University of Traditional Chinese Medicine
- Investigators
- Xi Wu, A.P., Study director, School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534130
- Sponsor's protocol ID
- 30801488
- Status last verified
- Feb 2020
- First submitted
- 14 Dec 2011
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT01534130
- Acronym / sponsor ID
- 30801488
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome, Sleep Disorder, Adjustment, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Apr 2011 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Device: Acupuncture |
| sham acupuncture | Sham comparator | Device: Sham acupuncture |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Streitberger needles(Special No.16)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. | Device | acupuncture |
| Sham acupunctureAlso: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).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. | Device | sham acupuncture |
Primary outcome
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.
11 secondary outcomes
The Pittsburgh Sleep Quality Index(PSQI)
Time frame: Change from baseline in PSQI at 4 weeks
The Fatigue Severity Scale(FSS)
Time frame: Change from baseline in FSS at 4 weeks
The Somatic and Psychological Health Report(SPHR)
Time frame: Change from baseline in SPHR at 4 weeks
The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36)
Time frame: Change from baseline in SF-36 at 4 weeks
Sleep-wake rhythm
Time frame: Change from baseline in sleep-wake rhythm at 4 weeks
DSWS-REM sleep rhythm
Time frame: Change from baseline in DSWS-REM sleep rhythm at 4 weeks
REM sleep rhythm
Time frame: Change from baseline in REM sleep rhythm at 4 weeks
Sleep latency
Time frame: Change from baseline in sleep latency at 4 weeks
Total sleep time
Time frame: Change from baseline in total sleep time at 4 weeks
Sleep efficiency
Time frame: Change from baseline in sleep efficiency at 4 weeks
Percentage of every sleep stage
Time frame: Change from baseline in percentage of every sleep stage at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
Related trials for Chronic Fatigue Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Wu, A.P. study director
School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Chronic Fatigue Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sleep perception (time frame: Change from baseline in sleep perception at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.