SchizophreniaNCT00780884
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
A study testing acupuncture in people with Schizophrenia and Schizoaffective, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Apr 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
- capability to sign inform consent.
Who cannot join
- unstable physical illness
- drug or alchohol abuse or dependence
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Schizophrenia, Schizoaffective
- Being tested
- acupuncture
- Keywords
- acupuncture, schizophrenia, insomnia
- Medical subject headings
- Schizophrenia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
16 sessions of acupuncture treatment, twice a week.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture needles | Experimental | Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD. Receives: Device: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep efficiency
Measured: 8 weeks
Secondary outcomes (1)
anxiety and depression levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilana Kremer, MD, Principal investigator, Haemek Mediacl Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780884
- Sponsor's protocol ID
- 0015-08
- Status last verified
- Jun 2015
- First submitted
- 26 Oct 2008
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT00780884
- Acronym / sponsor ID
- 0015-08
- Conditions
- Schizophrenia, Schizoaffective
- Keywords
- acupuncture, schizophrenia, insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Oct 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acupuncture needles | Experimental | Device: acupunctureAcupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
- capability to sign inform consent.
Key exclusion criteria (2 listed)
- unstable physical illness
- drug or alchohol abuse or dependence
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 |
|---|---|---|
| acupuncture16 sessions of acupuncture treatment, twice a week. | Device | acupuncture needles |
Primary outcome
sleep efficiency
Time frame: 8 weeks
1 secondary outcome
anxiety and depression levels
Time frame: 8 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 23 Jun 2015.
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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.
Ilana Kremer, MD principal investigator
Haemek Mediacl Center
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 Schizophrenia and Schizoaffective, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 inclusion and 2 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 23 Jun 2015. 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 Israel. 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. 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?
sleep efficiency (time frame: 8 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 23 Jun 2015.