Study Stopped
Inadequate enrollement
Acupressure for Insomnia
AcuSnooze
Acupressure for Chronic Insomnia in Adults With Chronic Low Back Pain
1 other identifier
interventional
5
1 country
1
Brief Summary
The purpose of this study is to examine the effect of 6-weeks of relaxation acupressure compared to stimulating acupressure or a standard of care on sleep and daytime functioning. Also, to evaluate the ability of teaching acupressure using web-based applications. It is believed that self-administered relaxation acupressure will result in improvements of sleep quality and quantity as compared to stimulating acupressure or a standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Typical duration for not_applicable
1 active site
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
June 15, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2013
CompletedFebruary 6, 2017
February 1, 2017
2.5 years
June 16, 2011
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in the effect of 6-weeks of Relaxation Acupressure compared to Stimulating Acupressure or standard of care on chronic insomnia and daytime functioning.
Insomnia will be assessed/determined by daily sleep/wake diaries and the Insomnia Severity Index questionnaire. Sleep Diary: insomnia = \<85% sleep efficiency ratio. Daytime functioning will be determined by the Fatigue Severity Scale of Sleep Disorders (FSS).
6 weeks
Secondary Outcomes (1)
Success of teaching the acupressure interventions using a novel web-based application measured by an Acupressure Fidelity Form at week 1 and week 6.
6 weeks
Study Arms (3)
Standard of Care
NO INTERVENTIONParticipants will be asked to continue doing whatever their healthcare providers advise for their insomnia, but not to start any new treatments during the study. They will also be given a sleep hygiene handout as a standard of care. After six weeks, they will be reassessed and then provided the opportunity to engage in the web-based acupressure intervention.
Relaxation Acupressure
ACTIVE COMPARATORIn addition to being given a sleep hygiene handout as a standard of care, participants will be asked to apply pressure on each of following points (bilaterally where indicated). There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes done once daily.
Stimulating Acupressure
ACTIVE COMPARATORIn addition to being given a sleep hygiene handout as a standard of care, participants will be asked to apply pressure on each of following points (bilaterally where indicated). There are 6 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 10 points to stimulate. Each of the 10 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 30 minutes done once daily.
Interventions
Apply pressure (stimulate) to the 9 acupoints for 3 minutes per point giving a total treatment time of 27 minutes done once daily for a period of 6 weeks.
Apply pressure (stimulate) to the 10 excitatory acupoints for 3 minutes per point giving a total treatment time of 30 minutes done once daily for a period of 6 weeks.
Eligibility Criteria
You may qualify if:
- years of age
- Meet DSM-IV criteria for primary insomnia
- Insomnia must also be documented on two weeks of a baseline sleep diary
You may not qualify if:
- Diagnosis or high clinical suspicion of a sleep disorder other than insomnia
- Evidence of a unstable Axis I psychiatric disorder
- Evidence of an uncontrolled medical disorder or pain syndrome that affects sleep, causes daytime sleepiness, or is likely to be causally associated with the insomnia
- Current pharmacological or non-pharmacological insomnia treatment
- Routine overnight shift work
- Previous failed trial of acupuncture or acupressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Domino's Farm
Ann Arbor, Michigan, 48105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanna M Zick, ND, MPH
, Department of Family Medicine, University of Michigan
- PRINCIPAL INVESTIGATOR
Richard E Harris, PhD
, Departments of Anesthesiology and Internal Medicine, University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 22, 2011
Study Start
June 15, 2011
Primary Completion
December 15, 2013
Study Completion
December 15, 2013
Last Updated
February 6, 2017
Record last verified: 2017-02