NarcolepsyNCT03376568
Investigation of Clinical Feature and Brain Function in Narcoleptic Patients
An observational study of Narcolepsy and REM Sleep Behavior Disorder, run by Tang-Du Hospital at 1 site in China.
Trial summary
This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD Read more about this study
- Who is it for?
- Ages 10 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy, REM Sleep Behavior Disorder
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2016to 30 Dec 2019
- 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 10 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will need about 40 narcoleptic patients with /without RBD between 10 and 65 years of age,and about 20 age- and gender-matched control subjects.
Who may be able to join
- Narcolepsy meet to the international classification of sleep disorder,3rd edition (ICSD-3) , and RBD meet to the minimal diagnostic criteria according to the international Classification of Sleep, control subjects .
Who cannot join
- History of heart disease History of central nervous system organic psychosis AHI>15次/h History of alcohol dependence and drug abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710000
Guoyan Chen, MD, 86-02984717792, chenguoyan29@126.com
Wen Wang, PhD, 86-029778689, wangwen@fmmu.edu.cn
About this study
Official title: Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject
This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD
Read the detailed description
Polysomnographic (PSG) work-up one night to record nocturnal sleep condition in narcolepsy with /without RBD and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(SOREMP), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated.
Functional magnetic resonance imaging (fMRI) has been used in human to nonivasiverlyn investigate the neural mechanisms. This technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (BOLD) signal diffusion tensor imaging (DTI and voxel-based morphometry(VBM)
This study compare the feature of PSG and fMRI between narcolepsy with RBD, narcolepsy without RBD, control subject to evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD.
- Conditions
- Narcolepsy, REM Sleep Behavior Disorder
- Keywords
- polysomnographic, multiple sleep latency test, fMRI
- Medical subject headings
- Narcolepsy, REM Sleep Behavior Disorder
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 |
|---|---|---|
| Narcolepsy with RBD & Control | Narcolepsy with REM sleep disorder lable(20) and Control subjects lable(20) | |
| Narcolepsy with /without RBD | Narcolepsy with REM sleep disorder lable(20) and Narcolepsy without REM sleep disorderlable (20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
video-polysomnographic(PSG)
video-PSG monitor sleep from 9:00pm to 6:00am
Measured: up to 100 weeks
Secondary outcomes (2)
multiple sleep latency test (MSLT)
MSLT in the next day of PSG record daytime sleepiness
Measured: up to 100 weeks
functional magnetic resonance imaging (fMRI)
All narcolepsy with or withoutRBD accepts fMRI
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start28 Jan 2016
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376568
- Sponsor's protocol ID
- TDLL-201601-08
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject
- ClinicalTrials.gov ID
- NCT03376568
- Acronym / sponsor ID
- TDLL-201601-08
- Conditions
- Narcolepsy, REM Sleep Behavior Disorder
- Keywords
- polysomnographic, multiple sleep latency test, fMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 Dec 2017 (actual)
- 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.
This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD
Detailed description
Polysomnographic (PSG) work-up one night to record nocturnal sleep condition in narcolepsy with /without RBD and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(SOREMP), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated.
Functional magnetic resonance imaging (fMRI) has been used in human to nonivasiverlyn investigate the neural mechanisms. This technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (BOLD) signal diffusion tensor imaging (DTI and voxel-based morphometry(VBM)
This study compare the feature of PSG and fMRI between narcolepsy with RBD, narcolepsy without RBD, control subject to evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcolepsy with RBD & Control | – | –Narcolepsy with REM sleep disorder lable(20) and Control subjects lable(20) |
| Narcolepsy with /without RBD | – | –Narcolepsy with REM sleep disorder lable(20) and Narcolepsy without REM sleep disorderlable (20) |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will need about 40 narcoleptic patients with /without RBD between 10 and 65 years of age,and about 20 age- and gender-matched control subjects.
Key inclusion criteria (1 listed)
- Narcolepsy meet to the international classification of sleep disorder,3rd edition (ICSD-3) , and RBD meet to the minimal diagnostic criteria according to the international Classification of Sleep, control subjects .
Key exclusion criteria (1 listed)
- History of heart disease History of central nervous system organic psychosis AHI>15次/h History of alcohol dependence and drug abuse
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
video-polysomnographic(PSG)
Time frame: up to 100 weeks
video-PSG monitor sleep from 9:00pm to 6:00am
2 secondary outcomes
multiple sleep latency test (MSLT)
Time frame: up to 100 weeks
functional magnetic resonance imaging (fMRI)
Time frame: up to 100 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
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 Narcolepsy and REM Sleep Behavior Disorder, run by Tang-Du Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 18 Dec 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 China. 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?
Contact Guoyan Chen, MD (86-02984717792, chenguoyan29@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
video-polysomnographic(PSG) (time frame: up to 100 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 18 Dec 2017.