Circadian Rhythm Disorders Clinical Trial
Official title:
A Randomized, Subject and Investigator-blinded, Placebo Controlled, Cross-over, Multi-center Proof of Concept (PoC) Study to Assess the Wakefulness Promoting Effect, Safety, Tolerability, and PK of LML134 in Shift Work Disorder (SWD) Patients
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. the sleep latency in the multiple sleep latency test (MSLT) and the Karolinska Sleepiness Scale (KSS), respectively. Safety and PK of LML134 were also evaluated. In addition, novel methodologies to measure wakefulness and sleep were also to be tested and compared to gold standard methods like the MSLT and polysomnography (PSG) (at sites where staff have appropriate equipment and training). The aim of such comparisons was to evaluate the usefulness of the new technologies in clinical studies and provide preliminary validation data. This was a randomized, subject and investigator-blinded, placebo controlled, crossover, multi-center Proof of Concept (PoC) study with in-house simulated laboratory night shifts in patients with SWD. This non-confirmatory study included two treatment arms: LML134 and placebo. After a screening period, the treatment phase of the study consisted of two overnight stays in a sleep lab in each of two treatment periods, with a minimum one week wash-out in between.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04578249 -
Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
|
N/A | |
Recruiting |
NCT06129942 -
Light Therapy in Parkinson's Disease
|
N/A | |
Recruiting |
NCT06083831 -
The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients
|
||
Recruiting |
NCT05228444 -
Managing Sleep-wake Disruption Due to Hospitalisation: the Circadian Care Project
|
N/A | |
Active, not recruiting |
NCT04953754 -
Melatonin and Vaccine Response, Immunity, and Chronobiology Study
|
N/A | |
Not yet recruiting |
NCT05452096 -
SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health.
|
N/A | |
Completed |
NCT01327040 -
Light Sensitization Study
|
N/A | |
Completed |
NCT03331822 -
The Effects of Bright Light Exposure on ICU Nurses
|
N/A | |
Completed |
NCT03646084 -
Sleep and Circadian Intervention Program for Chronic Musculoskeletal Pain
|
N/A | |
Recruiting |
NCT04690504 -
Validation of Circadian Biomarkers in Patients With Sleep Disorders
|
||
Recruiting |
NCT06023654 -
Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer
|
||
Completed |
NCT03682185 -
The Healthy Patterns Sleep Study
|
Phase 3 | |
Recruiting |
NCT06346613 -
Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU
|
||
Recruiting |
NCT05309577 -
Self-Care for Dementia Caregivers
|
N/A | |
Completed |
NCT04157244 -
The Music, Sleep and Dementia Study
|
N/A | |
Completed |
NCT03468400 -
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire
|
||
Recruiting |
NCT04063332 -
Functionality of Endogenous Biological Clock in Sepsis
|
||
Recruiting |
NCT06329479 -
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)
|
N/A | |
Recruiting |
NCT04401189 -
The Role of Circadian Rhythms in Cancer-Related Symptoms
|
||
Completed |
NCT03684460 -
Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients
|
N/A |