Clinical trials: Disorders of Excessive Somnolence
Narcolepsy Type 1
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- Brilliance NT1 (NCT07455383)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Idiopathic Hypersomnia
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment.
- Trial name
- NCT05371483
- Testing
- 24-hour Ambulatory Blood Pressure Monitoring, Oculo-Cognitive Addition Test (OCAT)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Idiopathic Hypersomnia
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
- Trial name
- NCT03533114
- Testing
- JZP-258
- Where
- 63 sites in United States, Belgium and 6 more
- Volunteers
- 154 people
- Sponsor
- Jazz Pharmaceuticals
End Stage Renal Disease
Effects of Hemodialysis on the Sleep/Wake Cycle
The purpose of this study is to test a novel application of an existing treatment - using col dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment) during hemodialysis for its ability to…
- Trial name
- NCT00460863
- Testing
- using cool versus warm dialysate during hemodialysis
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Emory University
Obstructive Sleep Apnea of Adult, Insomnia
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) was designed to develop and evaluate a new approach (patient-centered outcomes and coordinated-care management [PCCM]) for the…
- Conditions
- Obstructive Sleep Apnea of Adult, Insomnia, Circadian Rhythm Sleep Disorder, Sleep Related Movement Disorders
- Trial name
- SMART DOCS (NCT02037438)
- Testing
- CONV care for the diagnosis and treatment of sleep disorders, PCCM for the diagnosis and treatment of sleep disorders
- Where
- United States
- Volunteers
- 1,836 people
- Sponsor
- Stanford University
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
Idiopathic Hypersomnia
Local Sleep in Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare and poorly studied disease characterized by excessive daytime sleepiness different from that of narcolepsy (sleep drunkness non-recuperative naps and nocturnal blackout).
- Trial name
- SL-HIP (NCT06153615)
- Testing
- EEG (64 electrodes), Cognitive task (SART), Pupillometry and eye tracking
- Where
- France
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA
The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness…
- Trial name
- HAROSA3 (NCT02739568)
- Testing
- Pitolisant (BF2.649)
- Where
- 6 sites in Bulgaria, North Macedonia
- Volunteers
- 389 people
- Sponsor
- Bioprojet
Narcolepsy Type 1, Idiopathic Hypersomnia
Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Links between sleep and food intake are manyfold. In healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (GI) foods. Conversely, high GI foods induce sleepiness.
- Trial name
- NARCOFOOD (NCT06484348)
- Testing
- Monitoring of eating behaviors, Monitoring of sleep/wake rhythm, Measure of nocturnal sleep parameters
- Where
- 2 sites in France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Excessive Daytime Sleepiness, Disorders of Excessive Somnolence
Feasibility and Acceptability of a 6-Week Myofunctional and Physical Activity Program for University Students With Excessive Daytime Sleepiness
The aim of this clinical trial is to examine the feasibility, acceptability and safety of a 6-week intervention (MYOPAP) which includes oropharyngeal myofunctional therapy, physical activity guidance, and sleep hygiene education…
- Trial name
- MYOPAP (NCT07879859)
- Testing
- MYOPAP Program
- Where
- Kuwait
- Volunteers
- 14 people
- Sponsor
- Kuwait University
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
Stress, Fatigue
Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue
Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery. Design: Randomized placebo-controlled study.
- Conditions
- Stress, Fatigue, Sleepiness
- Trial name
- NCT04515381
- Testing
- Therapeutic Touch, Control group
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Mardin Artuklu University
Narcolepsy
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg…
- Trial name
- NCT02821715
- Testing
- THN102 300/3, THN102 300/27
- Where
- 8 sites in Belgium, France
- Volunteers
- 51 people
- Sponsor
- Theranexus
Narcolepsy, Hypersomnia
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks.
- Trial name
- AUTOSOP (NCT00916253)
- Testing
- Modafinil
- Where
- 2 sites in France
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Restless Legs Syndrome, Insomnia
Restless Legs Syndrome Exercise Intervention
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS).
- Trial name
- NCT00258492
- Testing
- Aerobic exercise
- Volunteers
- 30 people
- Sponsor
- Northeastern Ohio Universities College of Medicine
Narcolepsy
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
- Trial name
- NCT01624480
- Testing
- Armodafinil
- Where
- 24 sites in United States, Finland
- Volunteers
- 40 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time.
- Trial name
- NCT07363720
- Testing
- TAK-861
- Where
- 25 sites in United States, France and 5 more
- Volunteers
- 98 people
- Sponsor
- Takeda
Obstructive Sleep Apnea
Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime…
- Trial name
- NCT04091425
- Testing
- TAK-925
- Where
- 18 sites in United States
- Volunteers
- 25 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Sleep Apnea, Obstructive
OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Our study aims to determine the frequency of individuals at high risk of obstructive sleep apnea, and excessive daytime sleepiness, as well as any potential association between these conditions and traffic accidents among a…
- Trial name
- NCT05175287
- Where
- Ecuador
- Volunteers
- 340 people
- Sponsor
- Respiralab
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