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

N

National Yang Ming Chiao Tung University

Status and phase

Completed
Phase 2

Conditions

Insomnia

Treatments

Other: ear acupressure
Other: sham ear acupressure

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 2 patient groups, including a placebo group

sham ear acupressure
Placebo Comparator group
Treatment:
Other: sham ear acupressure
ear acupressure
Experimental group
Treatment:
Other: ear acupressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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