Treatment Trials

8 Clinical Trials for Various Conditions

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RECRUITING
Pathophysiology of Circadian Rhythm Delayed Sleep Wake Phase Disorder
Description

The goal of this study is to understand factors that contribute to delayed sleep wake phase disorder (DSWPD). The investigators will examine whether patients with DSWPD exhibit alterations in circadian rhythms and sensitivity to light compared to healthy controls. The investigators will also test a new method of predicting circadian rhythms form a blood sample.

RECRUITING
Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Description

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.

COMPLETED
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Description

The purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (TST) and an advance in sleep onset times (shift earlier) compared to the control group.

COMPLETED
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Description

This study will test whether measuring the circadian clock during treatment of delayed sleep-wake phase disorder results in greater improvements in sleep compared to estimating the circadian clock.

RECRUITING
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Description

The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo. The hypotheses for this study include: * Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment. * Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.

COMPLETED
Validation of Circadian Biomarkers in Patients With Sleep Disorders
Description

Current methods for assessing circadian timing require sampling over hours (or even up to a day) while the patient is in controlled conditions. The investigators aim to develop a method that can estimate individual circadian time with a single blood sample taken at any time of the day or night. To do this, the investigators will use two state of the art methods, a plasma proteomics-based method to identify a panel of rhythmic proteins (extending our preliminary data) and a whole blood-derived monocyte-based method using a panel of 15 transcripts (to validate and extend a recent study). We will test both methods in a series of patients with circadian rhythm sleep disorders. We will validate separately the proteomics-based biomarker and the monocyte-based transcript biomarker, and also explore whether combining them can improve the accuracy of our timing estimates. In all cases, circadian phase estimates from the biomarker panels will be compared with those derived from plasma or saliva melatonin (the current "gold-standard" circadian phase marker).

ACTIVE_NOT_RECRUITING
Breath Biomarkers for Sleep Loss and Circadian Timing
Description

Insufficient sleep has both health and safety risks, but currently there are no quick, accurate and inexpensive ways to measure sleep deficiency. The current study aims to use a cutting-edge technology, small molecule analysis (e.g. metabolomics), to detect compounds in breath that reliably change with sleep-wake state and those whose levels vary by time of day.

ACTIVE_NOT_RECRUITING
Biomarkers for Circadian Timing in Healthy Adults
Description

Study investigators want to learn more about the underlying biological clock and to see if the timing of that clock can be estimated from a single blood sample.