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

Somnolence Disorder, Excessive Clinical Trial

— Somnobank  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998020
• Other study ID #: 9895
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: June 16, 2033

Study information

• Verified date: December 2023
• Source: University Hospital, Montpellier
• Contact: Pôle Recherche et Innovation
• Phone: 0033467330913
• Email: depotac[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 16, 2033
• Est. primary completion date: June 16, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Parasomnias
• Sleep Wake Disorders
• Sleepiness
• Somnolence Disorder, Excessive

Intervention

Other:
• scale of severity
assessment of the severity of the sleep disorders by scale

Genetic:
• blood sample
Genetical study, serum and sample

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	INSERM U1061 Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of somnolence	evaluation with sleep latency test, validated questionnaires	Inclusion
Secondary	level of somnolence	Physicians Global Assessment to measure the evolution of somnolence	12 months maximum