Clinical trials: Disorders of Excessive Somnolence
Narcolepsy
TElemedicine for NARcolepsy
The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy.
- Trial name
- TENAR (NCT04316286)
- Testing
- Tele-multidisciplinary care, Standard care
- Where
- Italy
- Volunteers
- 202 people
- Sponsor
- Azienda Usl di Bologna
Idiopathic Hypersomnia
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia.
- Trial name
- NCT05837091
- Testing
- Low Sodium Oxybate, 24-hour polysomnography, Nextsense EEG earbuds
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mayo Clinic
ADHD, Narcolepsy
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant…
- Trial name
- SEAL (NCT04647903)
- Testing
- ADAIR 10 mg IR tablets, d-amphetamine sulfate
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Disorders of Excessive Somnolence
Test-retest Reliability of the Maintenance of Wakefulness Test in Participants With Hypersomnolence
This study will provide the first measurement of the test-retest reliability of the Maintenance of Wakefulness Test (MWT) with a prospective multicenter design.
- Trial name
- REWIND (NCT07120061)
- Testing
- First MWT, second MWT, actimetry
- Where
- 4 sites in France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Sleep-Wake Disorders, Healthy
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
- Trial name
- NCT03823105
- Testing
- OHR Tracker and PulseWatch
- Where
- Switzerland
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Treatment of Excessive Daytime Sleepiness in Narcolepsy
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
3. RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the generation and organizations of sleep and wakefulness, first described by Westphal and Gelineau in 19th century.
- Trial name
- NCT01638403
- Testing
- BF2.649, Vigil, palcebo
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Bioprojet
Myotonic Dystrophy 1, Excessive Daytime Sleepiness
Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.
- Trial name
- NCT04886518
- Testing
- Pitolisant Oral Tablet
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Harmony Biosciences Management, Inc.
Idiopathic Hypersomnia, Narcolepsy Type 1
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS).
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
- Trial name
- NCT07646678
- Testing
- TAK-360
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- Takeda
Sleep Apnea, Insomnia
Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease.
- Conditions
- Sleep Apnea, Insomnia, Sleep Deprivation, Sleep Disorders, Circadian Rhythm
- Trial name
- NCT06336525
- Where
- United States
- Volunteers
- 3,680 people
- Sponsor
- Brigham and Women's Hospital
Hypersomnia, Idiopathic
Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms.
- Trial name
- IDAHO (NCT05150977)
- Testing
- Polysomnography
- Where
- Sweden
- Volunteers
- 69 people
- Sponsor
- Uppsala University
Traumatic Brain Injury
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury…
- Trial name
- NCT00983437
- Testing
- Armodafinil
- Where
- 61 sites in United States
- Volunteers
- 49 people
- Sponsor
- Cephalon, Inc.
Idiopathic Hypersomnia
a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
Idiopathic hypersomnia (IH) is a chronic disabling disorder characterized by excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia.
- Trial name
- HyperChrono (NCT06252571)
- Testing
- - Melatonin - Active light ttherapy
- Where
- France
- Volunteers
- 72 people
- Sponsor
- University Hospital, Strasbourg, France
Narcolepsy
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured…
- Trial name
- NCT07493265
- Testing
- E2086
- Where
- 57 sites in United States, Belgium and 8 more
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Central Nervous System Tumor, Pediatric, Fatigue
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy.
- Conditions
- Central Nervous System Tumor, Pediatric, Fatigue, Specific Disorders of Sleep
- Trial name
- NCT01348607
- Testing
- methylphenidate hydrochloride, modafinil
- Volunteers
- 1 people
- Sponsor
- University of South Florida
Narcolepsy, Idiopathic Hypersomnia
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder
- Trial name
- iSPHYNCS (NCT04330963)
- Where
- Switzerland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Narcolepsy 1, Idiopathic Hypersomnia
The Role of the Circadian System in Neurological Sleep-wake Disorders
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap…
- Trial name
- PNP (NCT03356938)
- Testing
- Sleep restriction, Sleep deprivation
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Esther Werth
Excessive Sleepiness
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have…
- Trial name
- NCT00711516
- Testing
- Armodafinil
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cephalon
Narcolepsy, Cataplexy
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- Harmony2 (NCT01067235)
- Testing
- BF2.649, BF2.649 add on Modafinil
- Where
- Switzerland
- Volunteers
- 14 people
- Sponsor
- Bioprojet
Excessive Sleepiness, Shift-work Disorder
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
- Trial name
- NCT04788953
- Testing
- Solriamfetol Oral Tablet
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Charles A. Czeisler, PhD, MD
Obstructive Sleep Apnea, Daytime Sleepiness
Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea
This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.
- Trial name
- NCT06395181
- Testing
- Whole Food Plant-Based Diet
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Mayo Clinic