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

NCT ID: NCT00832468

Last Updated: 2009-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Insomnia

Keywords

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insomnia ear acupressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sham ear acupressure

Group Type PLACEBO_COMPARATOR

sham ear acupressure

Intervention Type OTHER

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.

ear acupressure

Group Type EXPERIMENTAL

ear acupressure

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Institute of Traditional Medicine, National Yang-Ming University, Taiwan

Principal Investigators

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Yen-ying Kung, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Traditional Medicine, National Yang-Ming University and Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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97032R

Identifier Type: -

Identifier Source: org_study_id