Clinical trials: Sleepiness
Narcolepsy 1, Kleine-Levin Syndrome
Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714
Type 1 narcolepsy (NT1) is a chronic sleep disorder caused by the selective and irreversible loss of neurons from the hypothalamus, which synthesizes a neurotransmitter: hypocretin (Hcrt) / orexin.
- Trial name
- NARCOGLIE (NCT03754348)
- Testing
- PET scan with tracer injection [18F] DPA-714
- Where
- France
- Volunteers
- 78 people
- Sponsor
- University Hospital, Montpellier
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Hypersomnia, Sleepiness, Excessive Daytime
Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including…
- Trial name
- BIOSOM (NCT05183464)
- Testing
- saliva samples, Stanford sleepiness scale, Karolinska Sleepiness Scale
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Hospices Civils de Lyon
Parkinson Disease
Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor…
- Trial name
- NCT04441697
- Testing
- Multiple sleep latency tests
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Central Hospital, Nancy, France
Narcolepsy Type 1 (NT 1)
Extended-release Sodium Oxybate in Children
The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the…
- Trial name
- NCT06809803
- Testing
- Extended-release sodium oxybate, Non-extended-release oxybates
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Stanford University
Narcolepsy, Obstructive Sleep Apnea
Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life.
- Trial name
- PN-PROS (NCT05373979)
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- Boston Children's Hospital
Excessive Daytime Sleepiness, Cataplexy
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
- Conditions
- Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
- Trial name
- NCT02720744
- Testing
- FT218
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 212 people
- Sponsor
- Avadel
Sleep Apnea, Temporo-central Epilepsy
Sleep and Memory in Children
Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning is necessary for knowledge consolidation.
- Conditions
- Sleep Apnea, Temporo-central Epilepsy, Narcolepsy, High Intellectual Potential
- Trial name
- EnSOM (NCT02785328)
- Testing
- memory evaluation at V1 and V2 (with treatment), memory evaluation at V1 (without treatment), memory evaluation at V1 and V2 (without treatment)
- Where
- France
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Juvenile Idiopathic Arthritis
Chronic Non-inflammatory Pains in Rheumatopediatrics
The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.
- Trial name
- RHUMEDOL (NCT03740347)
- Testing
- Questionnaires
- Where
- France
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Narcolepsy
Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations
Narcolepsy type 1 (NT1) is a neurological disorder characterized by excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations while awake.
- Trial name
- NarcoGen (NCT06786377)
- Testing
- saliva sampling
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.
- Trial name
- NCT02611687
- Testing
- pitolisant
- Where
- 11 sites in Finland, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Narcolepsy
Metabolism Characteristics in the Children With Narcolepsy
A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children.
- Trial name
- Narcolepsy (NCT02799849)
- Testing
- Sleep and metabolism assessment
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Hospices Civils de Lyon
Healthy Participants
Perceived Barriers and Facilitators to Physical Activity in Turkish Youth
Physical activity is a key determinant of physical and mental health among youth; however, participation levels are often influenced by various perceived barriers and facilitators.
- Trial name
- NCT07320131
- Where
- Turkey (Türkiye)
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Istinye University
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
- Trial name
- NCT00244465
- Where
- 41 sites in Austria, Belgium and 7 more
- Volunteers
- 750 people
- Sponsor
- UCB Pharma
Insomnia Chronic, Narcolepsy
The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders
Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders.
- Conditions
- Insomnia Chronic, Narcolepsy, REM Sleep Behavior Disorder
- Trial name
- NCT06797284
- Testing
- Transcranial Magnetic Stimulation
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Second Affiliated Hospital of Soochow University
Excessive Daytime Sleepiness
Characterization of Children with Complaints of Excessive Daytime Sleepiness
10% of the population suffers from excessive daytime sleepiness. This can be explained by a variety of etiologies: psychiatric disorders, altered sleep quantity or quality, hypersomnia...
- Trial name
- CEPSDE (NCT06898008)
- Testing
- Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Hospices Civils de Lyon
Narcolepsy, Cataplexy
Provigil (Modafinil) Study by Taiwan Biotech Co.
The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat…
- Conditions
- Narcolepsy, Cataplexy, Sleep Disorders, Hypersomnolence
- Trial name
- NCT00174174
- Testing
- Modafinil
- Volunteers
- 30 people
- Sponsor
- National Taiwan University Hospital
Narcolepsy
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week…
- Trial name
- NCT00049803
- Testing
- sodium oxybate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 200 people
- Sponsor
- Orphan Medical
Perennial Allergic Rhinitis
The Role of Montelukast in Rhinitis and Sleep
The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round…
- Trial name
- NCT00590772
- Testing
- montelukast
- Volunteers
- 31 people
- Sponsor
- Penn State University