HypersomniaNCT00001664
Sleep Disorders of Patients With Diseases of the Nervous System
An observational study of Hypersomnia and Narcolepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hypersomnia, Narcolepsy, Nervous System Disease
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 1996to 7 Sep 2011
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Training Protocol for Various Sleep Disorders in Patients With Neurological Disorders
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.
Read the 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.
- Conditions
- Hypersomnia, Narcolepsy, Nervous System Disease, Sleep Disorder
- Keywords
- Narcolepsy, Polysomnography, Multiple Sleep Latency Test, Sleep Disorders, Hypersomnia, Periodic Leg Movements
- Medical subject headings
- Disorders of Excessive Somnolence, Narcolepsy, Nervous System Diseases, Sleep Wake Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start4 Dec 1996
- Study completion7 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersomniaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001664
- Sponsor's protocol ID
- 970070
- Other IDs
- 97-N-0070
- Status last verified
- 7 Sep 2011
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Protocol for Various Sleep Disorders in Patients With Neurological Disorders
- ClinicalTrials.gov ID
- NCT00001664
- Acronym / sponsor ID
- 970070
- Conditions
- Hypersomnia, Narcolepsy, Nervous System Disease, Sleep Disorder
- Keywords
- Narcolepsy, Polysomnography, Multiple Sleep Latency Test, Sleep Disorders, Hypersomnia, Periodic Leg Movements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 4 Dec 1996
- Study completion
- 7 Sep 2011
- First posted
- 4 Nov 1999 (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 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.
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.
Study design
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
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
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 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypersomnia and Narcolepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 0 inclusion and 2 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 Jul 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.
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 Jul 2017.