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Acupressure for Insomnia (AcuSnooze)

Primary Purpose

Insomnia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Acupressure
Stimulating Acupressure
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Acupressure, Insomnia, Sleep Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years of age
  • Meet DSM-IV criteria for primary insomnia
  • Insomnia must also be documented on two weeks of a baseline sleep diary

Exclusion Criteria:

  • 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

Sites / Locations

  • Domino's Farm

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard of Care

Relaxation Acupressure

Stimulating Acupressure

Arm Description

Participants 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.

In 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.

In 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Success of teaching the acupressure interventions using a novel web-based application measured by an Acupressure Fidelity Form at week 1 and week 6.
The success of learning acupressure via a web-based application will be assessed using an Acupressure Fidelity Form. The form will assess the participants ability to locate each acupressure point, demonstrate proper pressure/technique, and know the frequency of their treatments. Acupressure Form A is worth a total of 12 points while Form B is worth 13 points. Each correct answer is worth 1 point. We will consider our web based intervention "successful" if 95% of participants (49 of them) received a score of 100% at both visits.

Full Information

First Posted
June 16, 2011
Last Updated
February 2, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01378793
Brief Title
Acupressure for Insomnia
Acronym
AcuSnooze
Official Title
Acupressure for Chronic Insomnia in Adults With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollement
Study Start Date
June 15, 2011 (Actual)
Primary Completion Date
December 15, 2013 (Actual)
Study Completion Date
December 15, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Insomnia is a significant health problem and is associated with increased mental health issues: It is estimated that 9% to 15% of the adult population suffers from chronic insomnia. These estimates are considerably higher in primary care where from 20% to 33% suffer from chronic insomnia. Insomnia adversely affects psychological, physical and occupational functioning and places a significant burden on society. Moreover, several cohort studies have found that people with insomnia have significantly higher absenteeism at work, report poor self-esteem, less job satisfaction, and less efficiency at work compared to good sleepers. Acupressure is a TCM technique based on a philosophy similar to that of acupuncture (the placement and stimulation of very fine needles into acupuncture points). Acupressure involves placing physical pressure by fingers, thumb, elbow, or with the aid of various devices such as pencil erasers on different acupuncture points (acupoints). Depending on the date of the review and the inclusion criteria, e.g., searched in Chinese language databases, there are anywhere from 7^12 to 4^68 randomized clinical trials (RCT) of various types of acupuncture (inclusive of acupressure) for treating insomnia. Regardless of the review the conclusions are remarkably consistent. Mainly, that the majority of RCTs demonstrated that acupuncture was significantly more effective than BDZs, sleep hygiene counseling, no treatment and sham acupuncture for treating insomnia. The investigators will attempt to prove that self-administered Relaxation Acupressure (RA) will result in improvements in measures of sleep quality and quantity, compared to Stimulating Acupressure (SA) and a wait list control (WL). Also, that they will be able to teach the acupressure points using a web-based application. Participants will be randomized into 1 of 3 arms; RA, SA, or WL (standard of care). If randomized into one of the acupressure arms, the participants will view their appropriate acupressure training lesson online and be tested on their understanding. They will also be asked to perform their acupoints once per day for a total of 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Acupressure, Insomnia, Sleep Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants 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.
Arm Title
Relaxation Acupressure
Arm Type
Active Comparator
Arm Description
In 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.
Arm Title
Stimulating Acupressure
Arm Type
Active Comparator
Arm Description
In 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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Acupressure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stimulating Acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in the effect of 6-weeks of Relaxation Acupressure compared to Stimulating Acupressure or standard of care on chronic insomnia and daytime functioning.
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Success of teaching the acupressure interventions using a novel web-based application measured by an Acupressure Fidelity Form at week 1 and week 6.
Description
The success of learning acupressure via a web-based application will be assessed using an Acupressure Fidelity Form. The form will assess the participants ability to locate each acupressure point, demonstrate proper pressure/technique, and know the frequency of their treatments. Acupressure Form A is worth a total of 12 points while Form B is worth 13 points. Each correct answer is worth 1 point. We will consider our web based intervention "successful" if 95% of participants (49 of them) received a score of 100% at both visits.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age Meet DSM-IV criteria for primary insomnia Insomnia must also be documented on two weeks of a baseline sleep diary Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanna M Zick, ND, MPH
Organizational Affiliation
, Department of Family Medicine, University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard E Harris, PhD
Organizational Affiliation
, Departments of Anesthesiology and Internal Medicine, University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Domino's Farm
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

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Acupressure for Insomnia

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