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

NCT03998020 | Recruiting

• 1 other identifier: 9895
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Somnolence Disorder, Excessive

Outcome Measures

Primary Outcomes (1)

• Severity of somnolence

  evaluation with sleep latency test, validated questionnaires

  Inclusion

Secondary Outcomes (1)

• level of somnolence

  12 months maximum

Study Arms (1)

chronic sleep disorders

OTHER

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; Genetic: blood sample

Interventions

scale of severity OTHER

assessment of the severity of the sleep disorders by scale

chronic sleep disorders

blood sample GENETIC

Genetical study, serum and sample

chronic sleep disorders

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a complaint of chronic hypersomnolence on questioning, identified by a sleep specialist and requiring objective explorations in the Centre de Hypersomnias Rares, with or without a diagnosis of chronic sleep disorder according to the International Classification scale in force at the time of diagnosis
• 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

You may not qualify if:

• be private of liberty
• live in medical institution
• be a major protected by law
• not have social security system
• refuse to participate in protocol

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• INSERM U1061 Montpellier: collaborator

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pôle Recherche et Innovation

CONTACT

0033467330913; depotac@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention = Blood withdrawal

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: June 25, 2019
• Study Start: June 16, 2020
• Primary Completion (Estimated): June 16, 2030
• Study Completion (Estimated): June 16, 2033
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)