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Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

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ClinicalTrials.gov Identifier: NCT00780884
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:
Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning and quality of life. Although insomnia is most often treated with medication, a growing number of studies have demonstrated the efficiency of a variety of relaxation techniques, cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims to restore and maintain health through the stimulation of specific points on the body. Previous studies have demonstrated that acupuncture has a positive influence on a number of diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the aim of the present study is to examine the effects of acupuncture as a treatment for insomnia in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period, followes by an 8-week experimental period. During the experimental period, subjects receive acupuncture treatments twice a week. During the first week of the study (no-treatment period) and the last week of the experimental period, subjects' sleep is monitored with a wrist actigraph, and subjects complete a wide spectrum of questionnaires.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Device: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: acupuncture needles
Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD.
Device: acupuncture
16 sessions of acupuncture treatment, twice a week.



Primary Outcome Measures :
  1. sleep efficiency [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. anxiety and depression levels [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
  2. capability to sign inform consent.

Exclusion Criteria:

  1. unstable physical illness
  2. drug or alchohol abuse or dependence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780884


Locations
Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Ilana Kremer, MD Haemek Mediacl Center

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00780884     History of Changes
Other Study ID Numbers: 0015-08
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by HaEmek Medical Center, Israel:
acupuncture
schizophrenia
insomnia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders