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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | November 19, 2009 | ||||||||
| Start Date ICMJE | December 1996 | ||||||||
| Estimated Primary Completion Date | February 2000 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00001664 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sleep Disorders of Patients With Diseases of the Nervous System | ||||||||
| Official Title ICMJE | Training Protocol for Various Sleep Disorders in Patients With Neurological Disorders | ||||||||
| Brief Summary | The purpose of this study is to assist training doctors about different diseases of the nervous system affecting sleep. Patients selected to participate in this study will have any of a variety of sleep disorders. They will undergo several tests including an overnight recording of brain activity, eye movement, leg movement, breathing, heart rate, and other measures. Results of these tests will be used to better understand diseases causing sleep disorders and may be used to develop better treatments for them. |
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| Detailed Description | The objective of this protocol is to provide training in a broad range of neurological sleep disorders to clinical associates who are eligible for sitting in the Board examination of the Added Qualification of Clinical Neurophysiology administered by the American Board of Psychiatry and Neurology. This protocol is to supplement small accrual of research patients who are referred from within the NIH. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 120 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | February 2000 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Patients 5 years of age and older, with the following referring diagnoses: Narcolepsy Hypersomnia REM behavior disorder Frontal nocturnal dystonia Restless legs syndrome Insomnia Parasomnia Nocturnal epileptic seizure Nocturnal movement disorder Sleep-related diagnostic dilemma Sleep apnea associated with neurological disorders Patients who are ambulatory and who are able to comply with the study procedures. Patients who are able to understand and sign the informed consent. (Parent or guardian for minors). EXCLUSION CRITERIA: Patients who have been diagnosed with acute and progressive neurological disorders. Patients who are unable to comply with the study procedures and require other than standard care. |
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| Gender | Both | ||||||||
| Ages | 5 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001664 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 970070, 97-N-0070 | ||||||||
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | November 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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