Sleep DisordersNCT02874261
Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
A study testing Whole Body Periodic Acceleration in people with Sleep Disorders and Physical Activity, run by New York Institute of Technology at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Physical Activity
- What is being tested?
- Whole Body Periodic Acceleration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals between the ages of 50-80
- Individuals with Parkinsons disease between the ages of 50-80
- Individuals with a smart phone
Who cannot join
- Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
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.
Read the 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.
- Conditions
- Sleep Disorders, Physical Activity
- Being tested
- Whole Body Periodic Acceleration
- Medical subject headings
- Sleep Wake Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Periodic AccelerationDevice
Also called WBPA
oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Periodic Acceleration | Experimental | 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. Receives: Device: Whole Body Periodic Acceleration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (2)
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
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronica Southard, DPT, Principal investigator, NYIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874261
- Sponsor's protocol ID
- BHS-1124
- Status last verified
- Sep 2017
- First submitted
- 17 Aug 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02874261
- Acronym / sponsor ID
- BHS-1124
- Conditions
- Sleep Disorders, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Body Periodic Acceleration | Experimental | Device: Whole Body Periodic AccelerationWhole-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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals between the ages of 50-80
- Individuals with Parkinsons disease between the ages of 50-80
- Individuals with a smart phone
Key exclusion criteria (1 listed)
- Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body Periodic AccelerationAlso: WBPAoscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute. | Device | Whole Body Periodic Acceleration |
Primary outcome
Sleep patterns using an activity monitor on the wrist
Time frame: 6 weeks
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
2 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: 6 weeks
Physical Activity (steps per day using an activity monitor on the wrist)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Southard, DPT principal investigator
NYIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Periodic Acceleration in people with Sleep Disorders and Physical Activity, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep patterns using an activity monitor on the wrist (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.