The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia

This study has been completed.
Sponsor:
Information provided by:
National Yang Ming University
ClinicalTrials.gov Identifier:
NCT00832468
First received: January 29, 2009
Last updated: December 7, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Insomnia
Other: ear acupressure
Other: sham ear acupressure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia and Anxiety

Resource links provided by NLM:


Further study details as provided by National Yang Ming University:

Primary Outcome Measures:
  • polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pittsburgh sleep quality index, Heart rate variability, SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832468

Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
National Yang Ming University
Investigators
Principal Investigator: Yen-ying Kung, MD Institute of Traditional Medicine, National Yang-Ming University and Taipei Veterans General Hospital, Taiwan
  More Information

Additional Information:
No publications provided

Responsible Party: Yen-Ying Kung, Institute of Traditional Medicine, National Yang-Ming University, Taiwan
ClinicalTrials.gov Identifier: NCT00832468     History of Changes
Other Study ID Numbers: 97032R
Study First Received: January 29, 2009
Last Updated: December 7, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Yang Ming University:
insomnia
ear acupressure

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014