Clinical trials: Excessive Daytime Sleepiness
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
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
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
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.
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
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
Sleep Disturbance
Bonafide Sleep Supplement for Menopausal Women With Sleep Complaints
This open-label study was designed to evaluate whether a daily dietary sleep supplement could improve sleep quality and related daytime well-being in menopausal women aged 40 to 65 with sleep complaints.
- Trial name
- NCT07839312
- Testing
- S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Bonafide Health
Obstructive Sleep Apnea
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe.
- Trial name
- NCT00307957
- Testing
- Pillar Palatal Implants
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Excessive Daytime Sleepiness
Alternative Epworth Sleepiness Scale ESS-ALT in French
The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.
- Trial name
- SOMNOLD (NCT05822128)
- Testing
- Test of an alternative Epworth Sleepiness Scale ESS-ALT in French
- Where
- 2 sites in France
- Volunteers
- 102 people
- 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
Obstructive Sleep Apnea, Excessive Daytime Sleepiness
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.
- Trial name
- HAROSA1 (NCT01071876)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 244 people
- Sponsor
- Bioprojet
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
Myotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants…
- Trial name
- NCT03959189
- Testing
- ERX-963
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Expansion Therapeutics, Inc.
Parkinson's Disease
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime…
- Trial name
- HARPS1 (NCT01036139)
- Testing
- BF2.649 (pitolisant)
- Where
- France
- Volunteers
- 268 people
- Sponsor
- Bioprojet
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