Clinical trials: Disorders of Excessive Somnolence
Narcolepsy, Idiopathic Hypersomnia
Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor…
- Trial name
- NCT03904238
- Testing
- Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
Excessive Daytime Sleepiness
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep…
- Trial name
- NCT05223166
- Testing
- Pitolisant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Citrine Medicine Limited
Sleep Apnea, Hypersomnia
Patient Outcomes in Unattended and In- Lab Polysomnography
This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and…
- Trial name
- NCT05230394
- Testing
- Attended Polysomnography in the Lab, Unattended Polysomnography in the Home
- Where
- Canada
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Cerebra Medical
Narcolepsy
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy…
- Trial name
- NCT02769780
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Jazz Pharmaceuticals
Parkinson's Disease
Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's Disease
The effect of varenicline, an alpha4beta2 nicotinic receptor partial agonist on excessive daytime sleepiness in Parkinson's disease will be studied in a randomized, double blind, placebo-controlled clinical trial with a…
- Trial name
- VESPA (NCT02473562)
- Testing
- Varenicline
- Where
- 2 sites in Netherlands
- Volunteers
- 22 people
- Sponsor
- Amsterdam UMC, location VUmc
Parkinson Disease
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease…
- Trial name
- Xyrem (NCT00641186)
- Testing
- sodium oxybate
- Volunteers
- 30 people
- Sponsor
- Baylor College of Medicine
Hypersomnia
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
1. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy. 2.
- Trial name
- tDCS (NCT03198156)
- Testing
- Transcranial Direct Current Stimulation
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Ohio State University
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness
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
- HAROSA IV (NCT02978651)
- Testing
- Pitolisant (BF2.649)
- Where
- 2 sites in France
- Sponsor
- Bioprojet
Narcolepsy, Cataplexy
An Open Label Study of FT218 in Subjects With Narcolepsy
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium…
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder
- Trial name
- RESTORE (NCT04451668)
- Testing
- FT218
- Where
- 29 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Avadel
Cerebral Stroke, Stroke, Acute
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.
- Conditions
- Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient
- Trial name
- NCT00061022
- Testing
- NXY-059
- Where
- 256 sites in United States, Argentina and 28 more
- Volunteers
- 3,200 people
- Sponsor
- AstraZeneca
Sleep Deprivation, Athletic Performance
Strategic Daytime Napping Enhances Agility and Lowers Perceived Exertion But Does Not Improve Fatigue Resistance in Adolescent Soccer Players
Background Daytime napping is increasingly incorporated into athletic recovery routines to manage sleepiness and support alertness.
- Conditions
- Sleep Deprivation, Athletic Performance, Fatigue
- Trial name
- NCT07314645
- Testing
- Pro Agility Test, Repeated-Sprint Ability (RSA) Test, Rate of Perceived Exertion (RPE)
- Where
- Turkey (Türkiye)
- Volunteers
- 16 people
- Sponsor
- Uludag University
Obstructive Sleep Apnoea, Excessive Daytime Sleepiness
Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
- Trial name
- NCT01620554
- Testing
- BF2.649
- Where
- France
- Volunteers
- 110 people
- Sponsor
- Bioprojet
Sleep Apnea
A Combined Surgical and Medical Approach in Mild Sleep Apnea
The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.
- Trial name
- NCT00497120
- Testing
- acetazolamide, uvulopalatopharygoplasty
- Where
- Belgium
- Sponsor
- University Hospital, Antwerp
Narcolepsy Without Cataplexy, Idiopathic Hypersomnia
Clarithromycin Mechanisms in Hypersomnia Syndromes
The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia.
- Conditions
- Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy
- Trial name
- NCT04026958
- Testing
- Clarithromycin
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Emory University
Idiopathic Hypersomnia
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
- Trial name
- Vibrance-3 (NCT06843590)
- Testing
- ALKS 2680
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 126 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Narcolepsy Without Cataplexy
Awareness and Self-Compassion Enhancing Narcolepsy Treatment
The overall goal of this research is to test the effectiveness of a mindfulness-based intervention (MBI) for improving health-related quality of life as a complementary practice to standard care for narcolepsy.
- Conditions
- Narcolepsy, Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy
- Trial name
- ASCENT (NCT04306952)
- Testing
- Brief MBI, Standard MBI, Extended MBI
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Northwestern University
Narcolepsy
Narcolepsy - New Potential Treatment
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side…
- Trial name
- NCT02077036
- Testing
- Kinetic Oscillation Stimulation Device
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska University Hospital
Fatigue
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
The purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and…
- Trial name
- NCT00702637
- Testing
- Modafinil
- Volunteers
- 60 people
- Sponsor
- Craig Hospital
Excessive Sleepiness, Shift-work Disorder
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and…
- Trial name
- NCT06568367
- Testing
- Solriamfetol 150 mg, Solriamfetol 300 mg
- Where
- 49 sites in United States, Canada
- Volunteers
- 520 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder (MDD)
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
- Trial name
- NCT07901179
- Testing
- ALKS 7290 Dose
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Alkermes, Inc.