Clinical trials: Chronobiology Disorders
Shift Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder
Recovery and Early Sleep Tracking Using the SuperPatch REM Patch
A Phase 1 Feasibility Study of the SuperPatch REM Patch for Post-Night-Shift Sleep Recovery in NHS Doctors
- Conditions
- Shift Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder, Shift Work Sleep Disorders
- Trial name
- REST (NCT07785960)
- Testing
- SuperPatch REM Patch
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- SuperPatch Limited LLC
Irregular Sleep Wake Rhythm Disorder
A Study to Determine the Signs and Symptoms That Impact Daily Life of Participants With Irregular Sleep-Wake Rhythm Disorder
The primary purpose of this study is to determine the signs and symptoms of irregular sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients with Alzheimer's disease dementia (AD-D), AD-D…
- Trial name
- NCT04300569
- Testing
- Non-interventional
- Where
- 6 sites in United States
- Volunteers
- 37 people
- Sponsor
- Eisai Inc.
Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
- Conditions
- Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome
- Trial name
- NCT02776215
- Testing
- tasimelteon
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Vanda Pharmaceuticals
Circadian Dysregulation
Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers
The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.
- Trial name
- NCT00492011
- Testing
- Ramelteon
- Where
- 4 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Takeda
Non-24-Hour-Sleep-Wake Disorder
Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)
Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24). Non-24 is very common in people who are totally blind because light can not reset their body clock.
- Trial name
- NCT02130999
- Testing
- tasimelteon 20 mg capsule, tasimelteon 2 mg I.V.
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Sleep Disorders, Circadian Rhythm
Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
- Trial name
- NCT00593736
- Testing
- Ramelteon
- Where
- 42 sites in United States
- Volunteers
- 132 people
- Sponsor
- Takeda
Depression, Bipolar, Depression, Unipolar
Chronobiology and Depression: Circadian Analytics as a Biomarker for Depressive Subtypes
An objective measure of treatment response could be a valuable new tool in the armamentarium of depression management, and this holds true for stimulation-based and pharmacological therapies alike.
- Conditions
- Depression, Bipolar, Depression, Unipolar, Healthy
- Trial name
- NCT03538275
- Testing
- Monitoring test
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medibio Limited
Non-24-Hour Sleep-Wake Disorder
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
- Trial name
- NCT01163032
- Testing
- tasimelteon
- Where
- 28 sites in United States, Germany
- Volunteers
- 136 people
- Sponsor
- Vanda Pharmaceuticals
Insomnia, Sleep
Vestibular Nerve Stimulation to Improve Sleep
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings The…
- Conditions
- Insomnia, Sleep, Sleep Disorders, Circadian Rhythm
- Trial name
- NCT04219566
- Testing
- VeNS
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Neurovalens Ltd.
Narcolepsy, Sleep Apnea, Obstructive
Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness…
- Conditions
- Narcolepsy, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Shift-Work Sleep Disorder
- Trial name
- NCT00078312
- Testing
- CEP-10953 (Armodafinil)
- Where
- 50 sites in United States, Russia
- Volunteers
- 328 people
- Sponsor
- Cephalon
Smith Magenis Syndrome
Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)
The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes
- Trial name
- NCT02180451
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Vanda Pharmaceuticals
Pain, Back, Pain, Acute
Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches
This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive…
- Conditions
- Pain, Back, Pain, Acute, Sleep Disorder, Sleep Disorders, Circadian Rhythm
- Trial name
- RESTORE (NCT06505005)
- Testing
- Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SuperPatch Limited LLC
Non 24 Hour Sleep Wake Disorder
Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception
The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01218789
- Testing
- tasimelteon
- Where
- 7 sites in France
- Volunteers
- 140 people
- Sponsor
- Vanda Pharmaceuticals
Genetic Obesity, Obesity
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.
- Conditions
- Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency
- Trial name
- NCT03013543
- Testing
- Setmelanotide
- Where
- 58 sites in United States, Canada and 7 more
- Volunteers
- 213 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Non-24-Hour Sleep-Wake Disorder
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01430754
- Testing
- tasimelteon
- Where
- 22 sites in United States
- Volunteers
- 20 people
- Sponsor
- Vanda Pharmaceuticals
Circadian Rhythm Disorders
A Study to Assess the Wakefulness Promoting Effect, Safety, Tolerability, and Pharmacokinetics (PK) of LML134 in Shift Work Disorder
The main purpose of this study was to demonstrate that LML134 can increase wakefulness compared to placebo in patients with shift work disorder (SWD) measured by objective and subjective endpoints of wakefulness, i.e.
- Trial name
- NCT03141086
- Testing
- LML134
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Jet Lag Disorder, Jet Lag
A Study on the Effectiveness of a Dietary Supplement FitoAvia for Jet Lag
Purpose of the study: Evaluation of the effects of dietary supplement Fitoavia in people with dyssynchrony Objectives of the study: 1. Assessment of the condition of patients with jet lag of 4 hours or more 2.
- Conditions
- Jet Lag Disorder, Jet Lag, Jet Lag Type Insomnia, Cognition Improvement
- Trial name
- NCT07695870
- Testing
- Fitoavia, Questionnaire and Physical Exam, cognition tests
- Where
- Russia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- MiraxBioPharma
Sleep Disorders
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy…
- Trial name
- NCT01906866
- Testing
- Circadin 2/5/10 mg
- Where
- 28 sites in United States, Finland and 3 more
- Volunteers
- 125 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Obesity & Overweight, Circadian Rhythm Disorders
Effects of Akkermansia Muciniphila and Berberine Supplementation on Insulin Sensitivity in Night-shift Workers
Night shift work is associated with an increased risk of obesity, insulin resistance, and cardiometabolic disorders, largely due to circadian misalignment, disrupted sleep, and altered eating patterns.
- Conditions
- Obesity & Overweight, Circadian Rhythm Disorders, Gut Microbiota Modulation, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Trial name
- Shift2Health (NCT07440147)
- Testing
- Verum (A)
- Where
- Austria
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- FH Joanneum Gesellschaft mbH