Table 1.

Environmental and lifestyle approaches in clinical trials

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

Date of consultation: 12/12/2021 (Clinical trials: https://clinicaltrials.gov/)

RD registered dietitian, HIIT high intensity interval training, HPA hypothalamic/pituitary/adrenal, AD Alzheimer’s disease, LWT+Am BWL Late Wake Therapy plus morning bright light, EWT + PM BWL Early Wake Therapy plus evening bright light