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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Other: sham ear acupressure; Other: ear acupressure

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
polysomnography	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pittsburgh sleep quality index, Heart rate variability, SF-36	4 weeks

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (ESTIMATE): January 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2009
• Last Update Submitted That Met QC Criteria: December 7, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: insomnia; ear acupressure
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 97032R