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Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence (Somnobank)

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ClinicalTrials.gov Identifier: NCT03998020
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : November 30, 2020
Sponsor:
Collaborator:
INSERM U1061 Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease Intervention/treatment Phase
Somnolence Disorder, Excessive Other: scale of severity Genetic: blood sample Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Intervention = Blood withdrawal
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
chronic sleep disorders
Subjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample)
 Other: scale of severity
assessment of the severity of the sleep disorders by scale

Genetic: blood sample
Genetical study, serum and sample


Outcome Measures
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Primary Outcome Measures :
  1. Severity of somnolence [ Time Frame: Inclusion ]
    evaluation with sleep latency test, validated questionnaires


Secondary Outcome Measures :
  1. level of somnolence [ Time Frame: 12 months maximum ]
    Physicians Global Assessment to measure the evolution of somnolence


Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998020


Locations
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France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Yves DAUVILLIERS, MD    0033467337172    y-dauvilliers@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
INSERM U1061 Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03998020    
Other Study ID Numbers: 9895
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Disorders of Excessive Somnolence
Sleepiness
Nervous System Diseases
 Neurologic Manifestations
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias