REM Sleep Behavior DisorderNCT01674998
Understanding the Natural History of REM Sleep Behavior Disorder
An observational study of REM Sleep Behavior Disorder, run by The Parkinson's Institute at 1 site in United States.
Trial summary
The purpose of this research study is to determine if safe, simple and non-invasive tests such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify neurological disorders before typical symptoms occur. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to not given
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sleep disorders clinics Neurology practices Medical practices Sleep disorders support groups Web-based advertisements Community outreach
Who may be able to join
- Idiopathic REM sleep behavior
Who cannot join
- Parkinson's disease
- Alzheimer's disease
- Multiple system atrophy
- Dementia
- Minors
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Parkinson's Institute
Sunnyvale, California, 94085
Sak Sundarrajan, 800-786-2958 ext. 434, sleepstudy@thepi.org
Kathleen Comyns, MPH, 800-786-2958 ext. 434, sleepstudy@thepi.org
About this study
Official title: Understanding Autonomic Function in REM Sleep Behavior Disorder, Parkinsonism and Controls
The purpose of this research study is to determine if safe, simple and non-invasive tests such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify neurological disorders before typical symptoms occur. Researchers believe that early identification of these disorders could lead to treatments to prevent, delay, or slow the development of one of more of these diseases. Some people with REM sleep behavior disorder (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but many do not.
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- REM Sleep Behavior Disorder, RBD, Dream, Dreams
- Medical subject headings
- REM Sleep Behavior Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Parkinson's Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. William Langston, The Parkinson's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674998
- Sponsor's protocol ID
- 11-DAT-013
- Status last verified
- Aug 2012
- First submitted
- 27 Aug 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Autonomic Function in REM Sleep Behavior Disorder, Parkinsonism and Controls
- ClinicalTrials.gov ID
- NCT01674998
- Acronym / sponsor ID
- 11-DAT-013
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- REM Sleep Behavior Disorder, RBD, Dream, Dreams
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Parkinson's InstituteUniversity, hospital or other
- Study start
- Jul 2012
- First posted
- 29 Aug 2012 (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.
The purpose of this research study is to determine if safe, simple and non-invasive tests such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify neurological disorders before typical symptoms occur. Researchers believe that early identification of these disorders could lead to treatments to prevent, delay, or slow the development of one of more of these diseases. Some people with REM sleep behavior disorder (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but many do not.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sleep disorders clinics Neurology practices Medical practices Sleep disorders support groups Web-based advertisements Community outreach
Key inclusion criteria (1 listed)
- Idiopathic REM sleep behavior
Key exclusion criteria (5 listed)
- Parkinson's disease
- Alzheimer's disease
- Multiple system atrophy
- Dementia
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder, run by The Parkinson's Institute 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 29 Aug 2012.