The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
ear acupressure
sham ear acupressure
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring insomnia, ear acupressure
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of primary insomnia
Exclusion Criteria:
- diabetic neuropathy
- cardiac arrythmia
- liver disease (ALT> 120 U/L)
- renal disease (Cr> 2 mg/dl)
- severe depression
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
sham ear acupressure
ear acupressure
Arm Description
Outcomes
Primary Outcome Measures
polysomnography
Secondary Outcome Measures
Pittsburgh sleep quality index, Heart rate variability, SF-36
Full Information
NCT ID
NCT00832468
First Posted
January 29, 2009
Last Updated
December 7, 2009
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT00832468
Brief Title
The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia
Official Title
The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia and Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Yang Ming University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia. In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.
Detailed Description
Even though there have been many advances in the pharmacological treatment of insomnia, many patients with insomnia visit complementary and alternative medicine (CAM) specialists for help due to fear of the side effects of long-term treatment with hypnotics. Acupuncture is commonly used to treat insomnia in the field of CAM. Among the different methods of acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the auricular points), which has the advantage of being non-invasive and easily carried out, shows possible effects whereby there is improvement in the sleep quality of old adults. However, it is lacking of the evidence of the randomized controlled trial (RCT) of ear acupressure on insomnia.
Insomnia is related to homeostatic dysregulation of autonomic nervous system (ANS). Ear acupuncture and its related techniques are believed to act through the reticular formation and the ANS may thus result in an amelioration of illness.
In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.Besides, the changes of ANS function (measured by heart rate variability) are recorded to evaluate the role of ANS in the treatment of insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, ear acupressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sham ear acupressure
Arm Type
Placebo Comparator
Arm Title
ear acupressure
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ear acupressure
Intervention Description
The ear acupressure that is used involved a 0.3 cm-sized magnetic pellet on a 1 cm size sticky patch (Ching-Ming Co., Taiwan), which was placed on the bilateral ear Shenmen points; each of the points were pressed once a second for one minute (60 times) before sleep every night. The time period of the treatment course was four weeks.
Intervention Type
Other
Intervention Name(s)
sham ear acupressure
Intervention Description
The sham ear acupressure that was used involved a 1 cm size sticky patch placed on the bilateral ear Shenmen points. There was no magnetic pellet attached to the sticker and no need to press it.
Primary Outcome Measure Information:
Title
polysomnography
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh sleep quality index, Heart rate variability, SF-36
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of primary insomnia
Exclusion Criteria:
diabetic neuropathy
cardiac arrythmia
liver disease (ALT> 120 U/L)
renal disease (Cr> 2 mg/dl)
severe depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-ying Kung, MD
Organizational Affiliation
Institute of Traditional Medicine, National Yang-Ming University and Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://www.ym.edu.tw/sleep/
Description
Related Info
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The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia
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