Clinical trials: Daytime Sleepiness
Excessive Daytime Sleepiness, Parkinson Disease
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with…
- Trial name
- CASPAR (NCT03194217)
- Testing
- BEN-2001
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BenevolentAI Bio
Sleep Apnea, Obstructive, Excessive Daytime Sleepiness
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)
The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center…
- Trial name
- NCT06103825
- Testing
- Solriamfetol
- Where
- 26 sites in China
- Volunteers
- 204 people
- Sponsor
- Ignis Therapeutics (Suzhou) Limited
Hypersomnia, Sleepiness, Excessive Daytime
Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including…
- Trial name
- BIOSOM (NCT05183464)
- Testing
- saliva samples, Stanford sleepiness scale, Karolinska Sleepiness Scale
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Hospices Civils de Lyon
Obstructive Sleep Apnea (OSA), Excessive Daytime Sleepiness
SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study
Study aim: This study aims to use a new brainwave monitoring device that meassure brainwaves 24 hours a day to create better understanding of sleep-wake interplay as a biomarker for excessive daytime sleepiness because of…
- Trial name
- NCT06711159
- Testing
- continuous positive airway pressure
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Zealand University Hospital
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
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
Sleepiness, Daytime, Fatigue
Lifestyle Medicine Strategies for Combating Sleepiness and Fatigue in Professional Drivers
Sleep has a number of health benefits, including memory and learning, vitality and energy as well as high quality of life levels.
- Conditions
- Sleepiness, Daytime, Fatigue, Sleep Disorders, Circadian Rhythm
- Trial name
- HighWay2Health (NCT05096130)
- Testing
- Lifestyle Medicine Strategies
- Where
- Greece
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Thessaly
Sleepiness, Fatigue
Integral Physiological Adaptations to Carbohydrate Periodization
The purpose of this study is to examine the effect of long-term carbohydrate periodization protocols on sleep architecture, sleep quality, daytime sleepiness, physical performance, body composition, gut microbiome, and miRNA in…
- Conditions
- Sleepiness, Fatigue, Feeding Patterns, Daytime Sleepiness, Excessive
- Trial name
- IPACP (NCT05464342)
- Testing
- Evening LGI Carbohydrate Consumption Group, Evening HGI Carbohydrate Consumption, Evening NO-CHO Carbohydrate Consumption
- Where
- 2 sites in Cyprus, Greece
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Thessaly
Narcolepsy, Obstructive Sleep Apnea
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness
- Trial name
- NCT05008341
- Testing
- Solriamfetol 150 mg Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy, Excessive Daytime Sleepiness
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2…
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy
- Trial name
- NCT04923594
- Testing
- mazindol extended release
- Where
- 22 sites in United States
- Volunteers
- 67 people
- Sponsor
- NLS Pharmaceutics
Sleepiness, Daytime
Effects of Litebook EDGE™ Phototherapy on Academic Performance and Brain Activity
As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late.
- Trial name
- LiteBook (NCT05383690)
- Testing
- LED bright light treatment device
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mclean Hospital
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
Daytime Sleepiness
Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
The purpose of this study is to examine daytime sleepiness in a community context. This includes examining sleepiness in a large sample in terms of social/behavioral/environmental predictors and health-related outcomes, as well…
- Trial name
- NCT04176042
- Testing
- Track 1, Track 2
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Arizona
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
Insomnia, Blindness
Melatonin for Circadian Sleep Disorders in the Blind
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1).
- Conditions
- Insomnia, Blindness, Daytime Sleepiness
- Trial name
- NCT00911053
- Testing
- Melatonin, Regular Sleep Schedule, Light
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Oregon Health and Science 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
Nocturia, Daytime Sleepiness
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
- Trial name
- NCT02151253
- Testing
- Armodafinil
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Duke University
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
Narcolepsy With Cataplexy, Excessive Daytime Sleepiness
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).
- Trial name
- NCT01800045
- Testing
- Pitolisant
- Where
- Hungary
- Volunteers
- 103 people
- Sponsor
- Bioprojet
Suspected Sleep Apnea, Daytime Sleepiness
Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home
The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional…
- Trial name
- Telesleep (NCT00614952)
- Testing
- PSG (polysomnography), PR (respiratory polygraphy)
- Where
- Spain
- Volunteers
- 320 people
- Sponsor
- Sociedad Española de Neumología y Cirugía Torácica