Clinical trials: Biological Clock Disturbance
Sleep Deprivation, Circadian Rhythm Disorders
PBM Effects on Health and Well-being in Humans
The goal of this clinical study is to assess the effects of different photobiomodulation (PBM) conditions in men and women between 25 and 65 years old with daytime sleepiness/drowsiness and /or mild mood complaints but be…
- Trial name
- NCT05619133
- Testing
- PBM
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Seaborough Life Science B.V.
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
Circadian Rhythm Sleep Disorders
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.
- Trial name
- NCT00490945
- Testing
- VEC-162
- Where
- 2 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Smith-Magenis Syndrome, Circadian
Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.
- Trial name
- NCT02231008
- Testing
- tasimelteon
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Vanda 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.
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
Non-24 Hour Sleep-Wake Disorder, Blindness
Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects
The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour…
- Trial name
- NCT00972075
- Testing
- melatonin (Circadin)
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
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
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
Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction
Feasibility Study on the Use of Redormin®500 on Day-time Cognition
Randomized, double-blind, parallel groups, placebo-controlled, baseline/run-in period of 21 days followed by trial period of 21 days, digital phenotyping (sleep, cognitive/psychological parameters and HRV).
- Trial name
- NCT05684523
- Testing
- Valerian-Hop Extract
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Max Zeller Soehne AG
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
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
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders, Gene Mutations and Other Alterations Nec
- Trial name
- NCT06701396
- Testing
- Tasimelteon
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Vanda Pharmaceuticals
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
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
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
Sleep Disorders, Circadian Rhythm
Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift
The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts
- Trial name
- NCT02199847
- Testing
- Pharmaton® Caplets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Non-24-Hour Sleep-Wake Disorder
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer from Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01429116
- Testing
- tasimelteon
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Vanda Pharmaceuticals