Clinical trials: Drowsiness
Sleepiness in Athletes
Nutrients to Enhance Sleep Quality and Quantity
Identifying non-pharmacological means of enhancing sleep is an important area of research for elite athletes. Research completed at the AIS has identified that some athletes have difficulties falling and staying asleep during…
- Trial name
- NCT03288077
- Testing
- Tryptophan
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Narcolepsy
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.
- Trial name
- NCT07613710
- Testing
- Lu AH69593
- Where
- 2 sites in Finland
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy Participants, Narcolepsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
- Trial name
- NCT03748979
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Healthy Participants
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.
- Trial name
- NCT07801066
- Testing
- Metaxalone 640 mg, Metaxalone 800 MG
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Primus Pharmaceuticals
Narcolepsy, Obstructive Sleep Apnea
The Nuvigil and Provigil Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
- Trial name
- NCT01792583
- Testing
- Modafinil/armodafinil
- Where
- United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Cephalon, Inc.
Healthy
Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects
The study aims to evaluate the safety and pharmacokinetics of extended release and standard formulations of betahistine when administered as monotherapy and as compared to their safety and pharmacokinetics when co-administered…
- Trial name
- NCT01168336
- Testing
- Betahistine standard formulation, Betahistine Extended Release formulation
- Where
- 2 sites in Romania
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- OBEcure Ltd.
Excessive Somnolence
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.
- Trial name
- NCT00467441
- Testing
- VSF-173
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Sleep Deprivation, Sleepiness
Shift Hours' Impact on Fatigue and Tracking of Eye Dynamics
The goal of this clinical trial is to learn how night shift-induced sleep debt affects oculomotor patterns, attentional state, and diagnostic performance in emergency radiologists.
- Conditions
- Sleep Deprivation, Sleepiness, Eye-Tracking Technology, Radiologists
- Trial name
- SHIFTED (NCT07192380)
- Testing
- Electroencephalogram, Actigraphy, Eye Tracking
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IMADIS Technologies et Services
Excessive Daytime Sleepiness
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Trial name
- NCT07082829
- Testing
- ORX142 Tablets
- Where
- 3 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) 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, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
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
Sleep Deprivation
EEG Analysis for the Objective Assessment of Drowsiness
The objective of this clinical study is to develop solutions for the evaluation and management of drowsiness, based on 2 EEG sensors only, aiming at reducing the risk of accidents related to secondary hypersomnolence (sleepiness…
- Trial name
- MEEGASAFE (NCT05453643)
- Testing
- sleep deprivation patterns
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Physip S.A
Healthy, Narcolepsy
A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)
This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.
- Trial name
- NCT06619665
- Testing
- MK-6552, Modafinil
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function
A Randomized, 4-Period, Crossover Study to characterize the effects of tolperisone 200 mg and 400 mg (supratherapeutic dose) three times a day (TID) over 3 days of dosing on measures of simulated driving performance, cognitive…
- Trial name
- NCT04407377
- Testing
- Tolperisone Hydrochloride, Cyclobenzaprine Hydrochloride 10 MG
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Neurana Pharmaceuticals, Inc.
Healthy, Narcolepsy
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil.
- Trial name
- NCT06665230
- Testing
- MK-6552, Modafinil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Digestive System Disease, Sleepiness
Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.
- Conditions
- Digestive System Disease, Sleepiness, Crying
- Trial name
- NCT05829720
- Testing
- a2 Full Cream Milk, Conventional Milk (Weidendorf)
- Where
- 2 sites in China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
ADHD, Narcolepsy
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine…
- Trial name
- NCT04232644
- Testing
- ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals