Somnolence Disorder, ExcessiveSomnobankNCT03998020
Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
A study testing scale of severity and blood sample in people with Somnolence Disorder, Excessive, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Somnolence Disorder, Excessive
- What is being tested?
- scale of severity and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2020to 16 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- be private of liberty
- live in medical institution
- be a major protected by law
- not have social security system
- refuse to participate in protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Yves DAUVILLIERS, MD, 0033467337172, y-dauvilliers@chu-montpellier.fr
About this study
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.
Read the 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
- Conditions
- Somnolence Disorder, Excessive
- Being tested
- scale of severity, blood sample
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scale of severityOther
assessment of the severity of the sleep disorders by scale
blood sampleGenetic
Genetical study, serum and sample
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: scale of severity; Genetic: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of somnolence
evaluation with sleep latency test, validated questionnaires
Measured: Inclusion
Secondary outcomes (1)
level of somnolence
Physicians Global Assessment to measure the evolution of somnolence
Measured: 12 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start16 Jun 2020
- Primary completion16 Jun 2030 (estimated)
- Study completion16 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somnolence Disorder, ExcessiveStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention = Blood withdrawal
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1061 Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998020
- Sponsor's protocol ID
- 9895
- Acronym
- Somnobank
- Status last verified
- Dec 2023
- First submitted
- 10 Sep 2018
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence
- ClinicalTrials.gov ID
- NCT03998020
- Acronym / sponsor ID
- Somnobank / 9895
- Conditions
- Somnolence Disorder, Excessive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM U1061 Montpellier
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 16 Jun 2030 (estimated)
- Study completion
- 16 Jun 2033 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention = Blood withdrawal
| Arm | Type | Receives |
|---|---|---|
| chronic sleep disorders | Other | Other: scale of severity, Genetic: blood sampleSubjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- be private of liberty
- live in medical institution
- be a major protected by law
- not have social security system
- refuse to participate in protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scale of severityassessment of the severity of the sleep disorders by scale | Other | chronic sleep disorders |
| blood sampleGenetical study, serum and sample | Genetic | chronic sleep disorders |
Primary outcome
Severity of somnolence
Time frame: Inclusion
evaluation with sleep latency test, validated questionnaires
1 secondary outcome
level of somnolence
Time frame: 12 months maximum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scale of severity and blood sample in people with Somnolence Disorder, Excessive, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pôle Recherche et Innovation (0033467330913, depotac@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of somnolence (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.