Clinical trials: Disorders of Excessive Somnolence
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to…
- Trial name
- OSA_DM (NCT00801892)
- Testing
- Continuous Positive Airway Pressure (CPAP)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Eileen R. Chasens
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
Sleep, Relaxation
Sleep and Morning Wellbeing Study
The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.
- Conditions
- Sleep, Relaxation, Stress, Daytime Sleepiness
- Trial name
- NCT07311434
- Testing
- Sleep Supplement
- Where
- United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Athletic Greens International
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: 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…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
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 Without Cataplexy, Narcolepsy With Cataplexy
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval.
- Trial name
- NCT03433131
- Testing
- Pitolisant
- Where
- 71 sites in United States
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy Type 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
- Trial name
- Vibrance-2 (NCT06555783)
- Testing
- ALKS 2680
- Where
- 47 sites in United States, Australia and 6 more
- Volunteers
- 93 people
- Sponsor
- Alkermes, Inc.
Excessive Daytime Sleepiness, Narcolepsy
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Trial name
- NCT00228553
- Testing
- Armodafinil 100 to 250 mg/day
- Where
- 100 sites in United States, Australia and 5 more
- Volunteers
- 743 people
- Sponsor
- Cephalon
Excessive Daytime Sleepiness, Narcolepsy
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Trial name
- NCT00228566
- Testing
- Armodafinil
- Where
- 43 sites in United States
- Volunteers
- 247 people
- Sponsor
- Cephalon
Narcolepsy, Idiopathic Hypersomnia
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
- Trial name
- XYRISE (NCT07625280)
- Testing
- Xywav
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
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
Idiopathic Hypersomnia
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).
- Trial name
- NCT04091438
- Testing
- TAK-925
- Where
- 22 sites in United States, Japan
- Volunteers
- 28 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Narcolepsy
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults.
- Trial name
- NARCOWORK (NCT03173378)
- Testing
- Questionnaires
- Where
- France
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired…
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- Trial name
- SHARP (NCT04789174)
- Testing
- Solriamfetol
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy
Body Weight Regulation in Patients With Narcolepsy
This study will measure energy expenditure (the rate at which the body burns calories), physical activity and caloric intake in people with narcolepsy to learn more about how the risk of becoming overweight or diabetic may be…
- Trial name
- NCT00283894
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Abdominal Obesity
Effects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers
The study is a year-long health-behaviour intervention in obese, male truck-drivers to lose weight moderately by 10%, using monthly individual counseling.
- Trial name
- SF-Truck (NCT00893646)
- Testing
- weight loss counseling
- Where
- 3 sites in Finland
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- UKK Institute
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 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
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
Lumbar Disc Herniation, Obstructive Sleep Apnea Risk Management
Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep Apnea
Lumbar disc herniation is a common musculoskeletal condition that negatively affects quality of life, physical function, and daily activities.
- Trial name
- REHAB-TIME (NCT07522021)
- Testing
- Physiotherapy and Exercise Program
- Volunteers
- 60 people
- Sponsor
- Mardin Artuklu University