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

Not Applicable

Recruiting

• Conditions: Somnolence Disorder, Excessive
• Interventions: Other: scale of severity; Genetic: blood sample

• Registration Number: NCT03998020
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Study Start: 2020-06-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02
• Primary Completion: 2030-06-16
• Study Completion: 2033-06-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chronic sleep disorders	scale of severity	Subjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample)
chronic sleep disorders	blood sample	Subjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample)

Primary Outcome Measures

Name	Time	Method
Severity of somnolence	Inclusion	evaluation with sleep latency test, validated questionnaires

Secondary Outcome Measures

Name	Time	Method
level of somnolence	12 months maximum	Physicians Global Assessment to measure the evolution of somnolence

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France