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Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acupuncture

Sham acupuncture

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue Syndrome, Sleep Disorder, Adjustment, Acupuncture

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Chengdu university of Traditonal Chinese Medcine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

acupuncture

sham acupuncture

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Pittsburgh Sleep Quality Index(PSQI)

The Fatigue Severity Scale(FSS)

The Somatic and Psychological Health Report(SPHR)

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

Sleep-wake rhythm

DSWS-REM sleep rhythm

REM sleep rhythm

Sleep latency

Total sleep time

Sleep efficiency

Percentage of every sleep stage

Full Information

NCT ID

NCT01534130

First Posted

December 14, 2011

Last Updated

February 13, 2020

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01534130

Brief Title

Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Official Title

Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

April 2011 (Actual)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

West China Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Fatigue Syndrome

Keywords

Chronic Fatigue Syndrome, Sleep Disorder, Adjustment, Acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acupuncture

Arm Type

Experimental

Arm Title

sham acupuncture

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Acupuncture

Other Intervention Name(s)

Streitberger needles(Special No.16)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham acupuncture

Other Intervention Name(s)

Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).

Intervention Description

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.

Primary Outcome Measure Information:

Title

The sleep perception

Description

The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.

Time Frame

Change from baseline in sleep perception at 4 weeks

Secondary Outcome Measure Information:

Title

The Pittsburgh Sleep Quality Index(PSQI)

Time Frame

Change from baseline in PSQI at 4 weeks

Title

The Fatigue Severity Scale(FSS)

Time Frame

Change from baseline in FSS at 4 weeks

Title

The Somatic and Psychological Health Report(SPHR)

Time Frame

Change from baseline in SPHR at 4 weeks

Title

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

Time Frame

Change from baseline in SF-36 at 4 weeks

Title

Sleep-wake rhythm

Time Frame

Change from baseline in sleep-wake rhythm at 4 weeks

Title

DSWS-REM sleep rhythm

Time Frame

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

Title

REM sleep rhythm

Time Frame

Change from baseline in REM sleep rhythm at 4 weeks

Title

Sleep latency

Time Frame

Change from baseline in sleep latency at 4 weeks

Title

Total sleep time

Time Frame

Change from baseline in total sleep time at 4 weeks

Title

Sleep efficiency

Time Frame

Change from baseline in sleep efficiency at 4 weeks

Title

Percentage of every sleep stage

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xi Wu, A.P.

Organizational Affiliation

School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Chengdu university of Traditonal Chinese Medcine

City

Chengdu

State/Province

Si Chuan Province

ZIP/Postal Code

610075

Country

China

12. IPD Sharing Statement

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Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

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