Heart Valve DiseasesNCT01231776
Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass
A study testing electronic acupuncture in people with Heart Valve Diseases and Cardiopulmonary Bypass, run by Xijing Hospital at 2 sites in China.
Trial summary
Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Valve Diseases, Cardiopulmonary Bypass
- What is being tested?
- electronic acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2010to Feb 2011
- 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
- aging:18yr--65yr
- cardiopulmonary bypass
- NYHA ≤II and EF≥50%
- not illiterate person
Who cannot join
- neurological disease,mentality disorder
- abuse of alcohol
- long history of smoking
- sleep disorder before admitting to hospital
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Enrolling by invitation
Zhang Jinzhou
Xi'an, Shaanxi, 710032
- Recruiting
Zhang Jinzhou
Xi'an, Shaanxi, 710032
zhang jinzhou, MD, 86-29-84771022, jinzhouzhang2006@yahoo.com
About this study
Official title: Study of Acupuncture of Traditional Chinese Medicine
Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients with heart operations.
Read the detailed description
60 patients are divided into three groups. control group: no any intervention; experiment group 1: acupuncture are used in patients before cardiac operation; experiment group 2: acupuncture are used through all the course in hospital.
before operation, before discharge, one month after operation, two month after operation, the quality of sleep are evaluated. and comparisons will be made in three groups.
- Conditions
- Heart Valve Diseases, Cardiopulmonary Bypass
- Being tested
- electronic acupuncture
- Keywords
- cardiopulmonary bypass, sleep, acupuncture
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic acupunctureOther
applying a stimula on neiguang and shenmen through electronic acupuncture
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described Receives: Other: electronic acupuncture |
| acupuncture preoperative | Active comparator | acupuncture before operation for one week Receives: Other: electronic acupuncture |
| acupuncture in hospital | Active comparator | acupuncture all the time in hospital Receives: Other: electronic acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
multiple monitoring for sleeping
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- zhang jinzhou, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231776
- Sponsor's protocol ID
- 20100926
- Status last verified
- Sep 2010
- First submitted
- 28 Oct 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acupuncture of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT01231776
- Acronym / sponsor ID
- 20100926
- Conditions
- Heart Valve Diseases, Cardiopulmonary Bypass
- Keywords
- cardiopulmonary bypass, sleep, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 1 Nov 2010 (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.
Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients with heart operations.
Detailed description
60 patients are divided into three groups. control group: no any intervention; experiment group 1: acupuncture are used in patients before cardiac operation; experiment group 2: acupuncture are used through all the course in hospital.
before operation, before discharge, one month after operation, two month after operation, the quality of sleep are evaluated. and comparisons will be made in three groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | Other: electronic acupuncture |
| acupuncture preoperative | Active comparator | Other: electronic acupunctureacupuncture before operation for one week |
| acupuncture in hospital | Active comparator | Other: electronic acupunctureacupuncture all the time in hospital |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aging:18yr--65yr
- cardiopulmonary bypass
- NYHA ≤II and EF≥50%
- not illiterate person
Key exclusion criteria (4 listed)
- neurological disease,mentality disorder
- abuse of alcohol
- long history of smoking
- sleep disorder before admitting to hospital
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 |
|---|---|---|
| electronic acupunctureapplying a stimula on neiguang and shenmen through electronic acupuncture | Other | acupuncture in hospital, acupuncture preoperative, control group |
Primary outcome
multiple monitoring for sleeping
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
zhang jinzhou, MD principal investigator
Xijing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic acupuncture in people with Heart Valve Diseases and Cardiopulmonary Bypass, run by Xijing Hospital at 2 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang jinzhou, MD (86-029771022, jinzhouzhang2006@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multiple monitoring for sleeping (time frame: 24 hours). 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 Feb 2011.