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

Phase 2

Completed

• Conditions: Insomnia
• Interventions: Other: sham ear acupressure; Other: ear acupressure

• Registration Number: NCT00832468
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Primary Completion: 2009-11
• Status Verified: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-07
• Last Update Posted: 2009-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham ear acupressure	sham ear acupressure	-
ear acupressure	ear acupressure	-

Primary Outcome Measures

Name	Time	Method
polysomnography	4 weeks

Secondary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index, Heart rate variability, SF-36	4 weeks

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan