The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00832468|
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : December 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Other: ear acupressure Other: sham ear acupressure||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia and Anxiety|
|Study Start Date :||December 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||December 2009|
|Placebo Comparator: sham ear acupressure||
Other: sham ear acupressure
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.
|Experimental: ear acupressure||
Other: ear acupressure
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.
- polysomnography [ Time Frame: 4 weeks ]
- Pittsburgh sleep quality index, Heart rate variability, SF-36 [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832468
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 112|
|Principal Investigator:||Yen-ying Kung, MD||Institute of Traditional Medicine, National Yang-Ming University and Taipei Veterans General Hospital, Taiwan|