NCT00832468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 8, 2009

Status Verified

December 1, 2009

Enrollment Period

11 months

First QC Date

January 29, 2009

Last Update Submit

December 7, 2009

Conditions

Insomnia

Keywords

insomniaear acupressure

Outcome Measures

Primary Outcomes (1)

  • polysomnography

    4 weeks

Secondary Outcomes (1)

  • Pittsburgh sleep quality index, Heart rate variability, SF-36

    4 weeks

Study Arms (2)

sham ear acupressure

PLACEBO COMPARATOR
Other: sham ear acupressure

ear acupressure

EXPERIMENTAL
Other: ear acupressure

Interventions

ear acupressureOTHER

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.

ear acupressure
sham ear acupressureOTHER

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.

sham ear acupressure

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of primary insomnia

You may not qualify if:

  • diabetic neuropathy
  • cardiac arrythmia
  • liver disease (ALT\> 120 U/L)
  • renal disease (Cr\> 2 mg/dl)
  • severe depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Yen-ying Kung, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

December 8, 2009

Record last verified: 2009-12

Locations

TW(1)