Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence (Somnobank)
Primary Purpose
Somnolence Disorder, Excessive
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
scale of severity
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Somnolence Disorder, Excessive
Eligibility Criteria
Inclusion Criteria:
- following a diagnostic of chronic sleep disorders responsible to hypersomnolence with a score at the Epworth scale better than 10/24
- can be treated or not for chronic sleep disorder.
- speak and understand french
- should have a social security system
- should not have infectious or inflammatory pathology
Exclusion Criteria:
- be private of liberty
- live in medical institution
- be a major protected by law
- not have social security system
- refuse to participate in protocol
Sites / Locations
- UH MontpellierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
chronic sleep disorders
Arm Description
Subjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample)
Outcomes
Primary Outcome Measures
Severity of somnolence
evaluation with sleep latency test, validated questionnaires
Secondary Outcome Measures
level of somnolence
Physicians Global Assessment to measure the evolution of somnolence
Full Information
NCT ID
NCT03998020
First Posted
September 10, 2018
Last Updated
November 27, 2020
Sponsor
University Hospital, Montpellier
Collaborators
INSERM U1061 Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03998020
Brief Title
Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
Acronym
Somnobank
Official Title
Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
INSERM U1061 Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic sleep disorders result from multiple pathophysiological mechanisms and are often associated with severe hypersomnolence, responsible for major disability. Hypersomnolence may be secondary to sleep disturbances at night by sleep fragmentation, both overall in restless leg syndrome (RLS) or specific to slow or paradoxical sleep in parasomnias (sleepwalking, sleep behavior disorder). paradoxical). Attention-Deficit / Hyperactivity Disorder (ADHD) is another cause of secondary hypersomnolence, unsolved pathophysiology, leading to a major disturbance of alertness. More rarely, hypersomnolence may be primary (central hypersomnia), representing then the most severe form existing in humans. The best-known central hypersomnia is narcolepsy type 1 (NT1), affecting 0.02% of the population. It is thanks to the existence of well-characterized clinical, biological and neuropathological patients that its pathophysiology is better understood. It is due to a selective loss of hypothalamic neurons secreting orexin / hypocretin, in connection with a probable autoimmune process, in genetically predisposed subjects. Narcolepsy type 2 (NT2), idiopathic hypersomnia (HI) and Kleine-Levin syndrome (SKL), are rarer forms of central hypersomnia, the pathophysiology of which is still unknown, due to the small number of patients studied.
Detailed Description
Chronic sleep disorders result from multiple pathophysiological mechanisms and are often associated with severe hypersomnolence, responsible for major disability. Hypersomnolence may be secondary to sleep disturbances at night by sleep fragmentation, both overall in restless leg syndrome (RLS) or specific to slow or paradoxical sleep in parasomnias (sleepwalking, sleep behavior disorder). paradoxical). Attention-Deficit / Hyperactivity Disorder (ADHD) is another cause of secondary hypersomnolence, unsolved pathophysiology, leading to a major disturbance of alertness. More rarely, hypersomnolence may be primary (central hypersomnia), representing then the most severe form existing in humans. The best-known central hypersomnia is narcolepsy type 1 (NT1), affecting 0.02% of the population. It is thanks to the existence of well-characterized clinical, biological and neuropathological patients that its pathophysiology is better understood. It is due to a selective loss of hypothalamic neurons secreting orexin / hypocretin, in connection with a probable autoimmune process, in genetically predisposed subjects. Narcolepsy type 2 (NT2), idiopathic hypersomnia (HI) and Kleine-Levin syndrome (SKL), are rarer forms of central hypersomnia, the pathophysiology of which is still unknown, due to the small number of patients studied.
Chronic sleep disorders result from multiple pathophysiological mechanisms and the constitution of a clinical, neurophysiological and biological cohort, monocentric. Patients (minors or adults) suffering from chronic sleep disorders responsible for hypersomnolence will be recruited, followed by the Sleep Disorders Unit (UTSE) and the National Reference Center for Rare Hypersomnia (CNRH) in Montpellier. The number of topics to include depends on feasibility criteria including the rarity of certain sleep disorders and recruitment opportunities. At a minimum, 150 subjects per group will be recruited according to the following ratio: NT1 (33%), other central hypersomnias (NT2, HI, SKL, 33%), and hypersomnolence secondary to a neurological sleep or vigilance disorder (ADHD, RLS, parasomnias, 33%). A match on age and sex will be considered
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somnolence Disorder, Excessive
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention = Blood withdrawal
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic sleep disorders
Arm Type
Other
Arm Description
Subjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample)
Intervention Type
Other
Intervention Name(s)
scale of severity
Intervention Description
assessment of the severity of the sleep disorders by scale
Intervention Type
Genetic
Intervention Name(s)
blood sample
Intervention Description
Genetical study, serum and sample
Primary Outcome Measure Information:
Title
Severity of somnolence
Description
evaluation with sleep latency test, validated questionnaires
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
level of somnolence
Description
Physicians Global Assessment to measure the evolution of somnolence
Time Frame
12 months maximum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
following a diagnostic of chronic sleep disorders responsible to hypersomnolence with a score at the Epworth scale better than 10/24
can be treated or not for chronic sleep disorder.
speak and understand french
should have a social security system
should not have infectious or inflammatory pathology
Exclusion Criteria:
be private of liberty
live in medical institution
be a major protected by law
not have social security system
refuse to participate in protocol
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves DAUVILLIERS, MD
Phone
0033467337172
Email
y-dauvilliers@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
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