Clinical trials: Circadian Rhythm Disorders
Poor Sleep Quality, Gut Microbiome
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure…
- Conditions
- Poor Sleep Quality, Gut Microbiome, Gut Health, Inflammation
- Trial name
- NCT07848594
- Testing
- Overnight Active Temperature Regulation: Eight Sleep Pod System
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eight Sleep Inc.
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
Parkinson Disease
Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease
Light treatment was originally employed in Parkinson's disease (PD) to determine if it might be effective in treating co-existing symptoms of depression and insomnia.
- Trial name
- NCT02175472
- Testing
- Spectramax light therapy device, Control light device
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 92 people
- Sponsor
- PhotoPharmics, Inc.
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
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
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
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
An Exploratory Study of Chenghuang Circadian Rhythm Regulator in Subjects With Sleep Disorders
This is a single arm, open-label, self-controlled clinical study to evaluate the sleep and immunity improvement of Chenghuang Circadian Rhythm Regulator in adult subjects with sleep disorders.
- Trial name
- NCT07414381
- Testing
- Chenghuang Circadian Rhythm Regulator
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Shanghai Cell Therapy Group Co.,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
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders
- Trial name
- NCT04652882
- Testing
- Tasimelteon
- Where
- 17 sites in United States, Austria and 1 more
- Volunteers
- 43 people
- Sponsor
- Vanda Pharmaceuticals