Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

NCT01534130 | Completed

• 1 other identifier: 30801488
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

Chronic Fatigue Syndrome; Sleep Disorder, Adjustment; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline in sleep perception at 4 weeks

Secondary Outcomes (11)

• The Pittsburgh Sleep Quality Index(PSQI)

  Change from baseline in PSQI at 4 weeks

• The Fatigue Severity Scale(FSS)

  Change from baseline in FSS at 4 weeks

• The Somatic and Psychological Health Report(SPHR)

  Change from baseline in SPHR at 4 weeks

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

  Change from baseline in SF-36 at 4 weeks

• Sleep-wake rhythm

  Change from baseline in sleep-wake rhythm at 4 weeks

Study Arms (2)

acupuncture

EXPERIMENTAL

Device: Acupuncture

sham acupuncture

SHAM COMPARATOR

Device: Sham acupuncture

Interventions

Acupuncture DEVICE

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.

Also known as: Streitberger needles(Special No.16)

acupuncture

Sham acupuncture DEVICE

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.

Also known as: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).

sham acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• West China Hospital: collaborator

Study Sites (1)

Chengdu university of Traditonal Chinese Medcine

Chengdu, Sichuan, 610075, China

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Dyssomnias

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Xi Wu, A.P.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: February 16, 2012
• Study Start: April 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)