Table 1 Environmental and lifestyle approaches in clinical trials
From: Molecular regulations of circadian rhythm and implications for physiology and diseases
Environmental and lifestyle modifications | Disease indication | Purpose | Intervention/treatment | Clinical trial | Sponsor |
|---|---|---|---|---|---|
Alteration in light exposure | Stroke; Sleep; Apnea Syndromes; Depression; Anxiety | Investigate the impact of exposure to ergonomic circadian light on physiological and mental parameters in stroke patients admitted for rehabilitation. | Device: Circadian Light luminaries | NCT02186392 | Glostrup University Hospital, Copenhagen |
Alzheimer’s Disease | Determine effect and duration of timed therapeutic light, compared to control light on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function in women with Alzheimer’s Disease. | Device: Morning Simulated Sunlight Device: Non-therapeutic Red Light | NCT02502045 | Yale University | |
Depression-Postpartum | Establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and clarify relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO). | Device: Light therapy | NCT02769858 | University of Michigan | |
Sleep Disturbances | Develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia. | Other: Blue light Other: Red light | NCT01855126 | Rensselaer Polytechnic Institute | |
Seasonal Affective Disorder | Develop a new light therapy device with more blue light (blue enriched polychromatic light) to treat seasonal affective disorder. | Device: Original Energy Light Device: Original Energy Light prototype | NCT01048294 | University Medical Center Groningen | |
Concussion; Mild Post-Concussion Symptoms; Sleep Problems | Verify whether bright light therapy may be helpful in improving the sleep of patients with a recent history of mild traumatic brain injuries and if may also have other mood elevating effects. | Device: wavelength-1 bright light Device: wavelength-2 bright light | NCT01747811 | University of Arizona | |
Time-restricted feeding | Overweight Obesity; Weight Loss | Examine the influence of timing of eating on sleep patterns, physical activity, and self-reported feelings of appetite control. | Behavioral: Eat majority of calories in the morning Behavioral: Eat the majority of calories in the evening | NCT02204735 | The University of Tennessee, Knoxville |
Obesity; Abdominal Dyslipidemias; Insulin Resistance; Blood Pressure; Weight Loss | Develop and hone dietary counseling approaches for time restricted eating for RD’s in a clinical practice paradigm and collect data on testing this intervention compared to standard dietary counseling approaches for cardiometabolic health. | Behavioral: Time Restricted Eating Behavioral: Standard Cardiometabolic Health Diet | NCT03527290 | University of California, Irvine | |
Change in sleeping time | Traumatic Brain Injury | Monitor sleep efficiency, post traumatic amnesia, agitation and cognitive function and examine relationships among them. | Behavioral: Sleep Hygiene Protocol Behavioral: Standard of Care | NCT02838082 | Craig Hospital |
Breast Cancer | Verify whether improvement in sleep in women night shift workers will have a positive impact on biological and behavioral risk factors associated with breast cancer and quality of life. | Behavioral: Sleep intervention | NCT02609373 | University of British Columbia | |
Scheduled activity | Type 2 Diabetes; Insulin Independent | Compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. | Other: morning HIIT -->afternoon HIIT Other: afternoon HIIT -->morning HIIT | NCT03553524 | Karolinska Institute |
Alzheimer’s Disease | Characterize objective sleep parameters and behavioral symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in a sample of community residing older adults with AD; Examine the effects of timed and planned activities on subjective and objective characteristics of sleep, behavioral symptoms, and HPA status; Evaluate measurement approaches in home-dwelling AD patients. | Behavioral: Timed Planned Activity Behavioral: Home Safety and Education Program | NCT01920672 | Johns Hopkins University | |
Combination of: changing in light exposure; feed and physical activity | Critical Illness; Sleep Deprivation; Respiratory Failure; Sleep Disorders; Circadian Rhythm | Determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside. | Behavioral: Sleep and circadian rhythm promotion Behavioral: Usual care | NCT01284140 | Brian Gehlbach |
Healthy Night Shift Workers | Investigate the effects of 12 weeks of randomized timed light therapy or timed physical exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral circadian rhythms and cardiometabolic function in healthy night shift workers. | Other: Intensive light therapy Other: Exercise | NCT01767181 | Universitätsklinikum Hamburg-Eppendorf | |
Fatigue in HIV | Determine the overall feasibility of a behavioral intervention for managing fatigue among older adults with HIV infection. Estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions of fatigue. | Behavioral: Sleep and Rhythm Intervention Behavioral: Dietary Modifications | NCT02126007 | University of California, San Francisco | |
Premenstrual Dysphoric Disorder | Examine the effects of co-administered wake therapy followed by light treatment on mood, and secondarily on circadian rhythms, to test the hypothesis that critically timed chronotherapy improves mood by correcting phase disturbances in melatonin and sleep in women with Premenstrual Dysphoric Disorder. | Other: LWT + AM BWL Other: EWT + PM BWL | NCT01799733 | University of California, San Diego | |
Depression; Depressive Disorder, Major; Depression, Unipolar; Depression, Moderate | Determine whether altering the pattern of one’s sleep and having light therapy can speed up the treatment of depression. | Behavioral: Wake and Light Therapy Behavioral: Sleep and Light Therapy | NCT03405493 | King’s College London | |
Major Depressive Disorder; Bipolar Disorder | Replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects. | Behavioral: Wake Therapy Device: light box Drug: Lithium | NCT01431573 | New York State Psychiatric Institute |
