Rapid Eye Movement Sleep Behavior DisorderRBD6YRNCT00817726
RBD Longitudinal as Prognostic for PD
An observational study of Rapid Eye Movement Sleep Behavior Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Purpose - to validate a combination of biological and clinical markers in the rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the pre-symptomatic stage of Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rapid Eye Movement Sleep Behavior Disorder
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2025
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with polysomnographically-documented RBD, non-neurodegenerative diagnosis Age and gender matched non-RBD diagnosis, non-neurodegenerative diagnosis idiopathic PD diagnosis atypical PD diagnosis
Who may be able to join
- 35-70 year old men \& women
- (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1)
- Gives written informed consent
- Pregnant women are not excluded, but will be identified by HCG.
Who cannot join
- a A diagnosis of any non-Parkinsonian Neurodegenerative Disease.
- Any unstable or uncontrolled medical or psychiatric condition.
- Parasomnia or RBD not idiopathic, eg., secondary to metabolic derangement or medicine effect.
- Renal (creatinine over 1.6) or hepatic insufficiency (LFT significantly out of range), or a history of significant uncontrolled cardiac disease.
- Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study procedures or informed consent.
- Any reason which, in the opinion of the PI, would increase the risk or decrease the value of any study procedure.
- fMRI will not be performed for anyone for whom the screening questionnaire indicates is ineligible for MRI imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease
- Purpose - to validate a combination of biological and clinical markers in the rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the pre-symptomatic stage of Parkinson's disease (PD).
- Procedures - All subjects (RBD diagnosis and controls) will have 1) a medical and neuro history and physical including videotape of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw for serum testing , 6) functional MRI. All of these procedures are often performed clinically in the diagnosis of PD. Enrollment of subjects with PD is complete. Any testing performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure for the study. Subjects will be followed for 5 years. It is hypothesized that a 5 year follow up may capture a significant number of pre-Parkinson's subjects who will be diagnosed. Subjects may be offered a repeat enrollment after 5 years.
Read the detailed description
Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.
- Keywords
- Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease, Parkinsonian Syndromes, Atypical Parkinson's, RBD, PD, fMRI, PSP, MSA
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1- RBD | polysomnographically diagnosed RBD patients. RBD is a sleep disorder diagnosed by a sleep lab in which the individual has muscle movements during the phase of deep sleep during which the muscles should be relaxed. Suspicion of RBD by history will be confirmed during screening. | |
| 2 - control | control: * must not have any neurological degenerative diagnosis. * must NOT have RBD. * must be able to age and/or gender-match to RBD and PD subjects already enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the key cognitive and non-motor characteristics for early PD diagnosis
periodically performed set of clinical and imaging parameters suspected to be linked to PD to see if, as a group, these parameters could identify those at risk for motor symptoms of PD before these symptoms develop.
Measured: 5 years
Secondary outcomes (3)
Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients.
perform baseline sleep study, olfactory testing and clinical neurologic exam followed by periodically performed set of clinical parameters.
Measured: 5 years
functional MRI of the brain and eye tracking testing, identification of distinct features in PD
Perform fMRI at baseline and at 2 years followed by periodically performed set of clinical parameters.
Measured: beginning of study and at 2 years
identify key fluid-based PD-associated molecular markers that identify disease state or progression
parameters within blood may be present \& measurable well before motor symptoms of PD are seen.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Eye Movement 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-control
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mya Schiess, The University of Texas Health Science Center, Houston
- Investigators
- Mya C Schiess, MD, Principal investigator, The University fo texas Health Science Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817726
- Sponsor's protocol ID
- HSC-MS-08-0147
- Acronym
- RBD6YR
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2009
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00817726
- Acronym / sponsor ID
- RBD6YR / HSC-MS-08-0147
- Keywords
- Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease, Parkinsonian Syndromes, Atypical Parkinson's, RBD, PD, fMRI, PSP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 Jan 2009 (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.
- Purpose - to validate a combination of biological and clinical markers in the rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the pre-symptomatic stage of Parkinson's disease (PD).
- Procedures - All subjects (RBD diagnosis and controls) will have 1) a medical and neuro history and physical including videotape of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw for serum testing , 6) functional MRI. All of these procedures are often performed clinically in the diagnosis of PD. Enrollment of subjects with PD is complete. Any testing performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure for the study. Subjects will be followed for 5 years. It is hypothesized that a 5 year follow up may capture a significant number of pre-Parkinson's subjects who will be diagnosed. Subjects may be offered a repeat enrollment after 5 years.
Detailed description
Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- RBD | – | –polysomnographically diagnosed RBD patients. RBD is a sleep disorder diagnosed by a sleep lab in which the individual has muscle movements during the phase of deep sleep during which the muscles should be relaxed. Suspicion of RBD by history will be confirmed during screening. |
| 2 - control | – | –control: * must not have any neurological degenerative diagnosis. * must NOT have RBD. * must be able to age and/or gender-match to RBD and PD subjects already enrolled. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with polysomnographically-documented RBD, non-neurodegenerative diagnosis Age and gender matched non-RBD diagnosis, non-neurodegenerative diagnosis idiopathic PD diagnosis atypical PD diagnosis
Key inclusion criteria (4 listed)
- 35-70 year old men \& women
- (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1)
- Gives written informed consent
- Pregnant women are not excluded, but will be identified by HCG.
Key exclusion criteria (7 listed)
- a A diagnosis of any non-Parkinsonian Neurodegenerative Disease.
- Any unstable or uncontrolled medical or psychiatric condition.
- Parasomnia or RBD not idiopathic, eg., secondary to metabolic derangement or medicine effect.
- Renal (creatinine over 1.6) or hepatic insufficiency (LFT significantly out of range), or a history of significant uncontrolled cardiac disease.
- Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study procedures or informed consent.
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
Identify the key cognitive and non-motor characteristics for early PD diagnosis
Time frame: 5 years
periodically performed set of clinical and imaging parameters suspected to be linked to PD to see if, as a group, these parameters could identify those at risk for motor symptoms of PD before these symptoms develop.
3 secondary outcomes
Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients.
Time frame: 5 years
functional MRI of the brain and eye tracking testing, identification of distinct features in PD
Time frame: beginning of study and at 2 years
identify key fluid-based PD-associated molecular markers that identify disease state or progression
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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.
Mya C Schiess, MD principal investigator
The University fo texas Health Science Center at Houston
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 Rapid Eye Movement Sleep Behavior Disorder, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 7 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 Nov 2023. 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?
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?
Identify the key cognitive and non-motor characteristics for early PD diagnosis (time frame: 5 years). 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 29 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.