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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02874261
Other study ID # BHS-1124
Secondary ID
Status Completed
Phase N/A
First received August 17, 2016
Last updated September 28, 2017
Start date May 2015
Est. completion date June 2017

Study information

Verified date September 2017
Source New York Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Device:
Whole Body Periodic Acceleration
oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.

Locations

Country Name City State
United States NYIT Old Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 weeks
Secondary 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 6 weeks
Secondary 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 6 weeks
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