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Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease

Primary Purpose

Sleep Disorders, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Body Periodic Acceleration
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy individuals between the ages of 50-80
  • Individuals with Parkinsons disease between the ages of 50-80
  • Individuals with a smart phone

Exclusion Criteria:

  • Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease.

Sites / Locations

  • NYIT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole Body Periodic Acceleration

Arm Description

Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation is 120 cycles/minute; cpm) as well as a distance traveled 16 mm.

Outcomes

Primary Outcome Measures

Sleep patterns using an activity monitor on the wrist
The investigators will record sleep patterns a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist

Secondary Outcome Measures

Pittsburgh Sleep Quality Index
This is a quantitative tool to measure sleep as well as an activity monitor twenty -four hours for seven days at a time
Physical Activity (steps per day using an activity monitor on the wrist)
The investigators will record steps per day a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist

Full Information

First Posted
August 17, 2016
Last Updated
September 28, 2017
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02874261
Brief Title
Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Official Title
Effects of Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional. The science behind the therapeutic effects of WBPA still remains largely unknown. The investigators are observing how WBPA may impact on sleep and activity in individuals with Parkinson's disease.
Detailed Description
Sleep disturbances are common in individuals with Parkinson's Disease. Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." WBPA has been shown in previous studies to increase nitric oxide. Increased levels of nitric oxide have been shown to improve sleep patterns in other populations. The current pilot study will investigate how WBPA will impact upon sleep disturbances in subjects with Parkinson's disease who suffer from abnormal sleep patterns. The investigators will record sleep patterns and activity levels using a Jawbone U3® activity monitor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Periodic Acceleration
Arm Type
Experimental
Arm Description
Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation is 120 cycles/minute; cpm) as well as a distance traveled 16 mm.
Intervention Type
Device
Intervention Name(s)
Whole Body Periodic Acceleration
Other Intervention Name(s)
WBPA
Intervention Description
oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.
Primary Outcome Measure Information:
Title
Sleep patterns using an activity monitor on the wrist
Description
The investigators will record sleep patterns a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
This is a quantitative tool to measure sleep as well as an activity monitor twenty -four hours for seven days at a time
Time Frame
6 weeks
Title
Physical Activity (steps per day using an activity monitor on the wrist)
Description
The investigators will record steps per day a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals between the ages of 50-80 Individuals with Parkinsons disease between the ages of 50-80 Individuals with a smart phone Exclusion Criteria: Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Southard, DPT
Organizational Affiliation
NYIT
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYIT
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568568
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease

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