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Non-24 Hour Sleep-Wake Disorder clinical trials

View clinical trials related to Non-24 Hour Sleep-Wake Disorder.

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NCT ID: NCT03980340 Active, not recruiting - Clinical trials for Sleep Disorders, Circadian Rhythm

Breath Biomarkers for Sleep Loss and Circadian Timing

Start date: January 28, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT03956745 Recruiting - Clinical trials for Sleep Disorders, Circadian Rhythm

Biomarkers for Circadian Timing in Healthy Adults

Start date: June 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT02776215 Completed - Clinical trials for Autism Spectrum Disorder

Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Start date: October 4, 2016
Phase: Phase 1
Study type: Interventional

Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.

NCT ID: NCT02130999 Completed - Clinical trials for Non-24-Hour-Sleep-Wake Disorder

Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)

Start date: May 2014
Phase: Phase 4
Study type: Interventional

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. This causes the internal sleep-wake cycle to be out of sync with the 24-hour day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming urge to nap. Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and intravenously (I.V.) by infusion through a catheter (not an injection) into a vein. The oral administration is approved by the FDA. The I.V. administration is considered investigational as it has not been approved by the FDA. This will be the first time tasimelteon will be given to humans by intravenous (I.V.) injection. The purposes of this research study are to: - assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body; - evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose and after a single 2 mg I.V. dose; - evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20 mg oral dose and after a single 2 mg I.V. dose; - evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and - evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.

NCT ID: NCT01430754 Completed - Clinical trials for Non-24-Hour Sleep-Wake Disorder

Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder

Start date: September 2011
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01429116 Completed - Clinical trials for 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

Start date: October 2011
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01218789 Active, not recruiting - Clinical trials for 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

Start date: October 28, 2010
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01163032 Completed - Clinical trials for Non-24-Hour Sleep-Wake Disorder

Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder

NCT ID: NCT00972075 Completed - Blindness Clinical Trials

Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

Start date: February 2006
Phase: Phase 2
Study type: Interventional

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 sleep-wake disorder.