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Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

2014-08-27 03:15:28 | BioPortfolio

Summary

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Excessive Sleepiness

Intervention

Armodafinil, Placebo

Location

REM Medical Sleep Center
Phoenix
Arizona
United States
85037

Status

Recruiting

Source

Cephalon

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:28-0400

Clinical Trials [187 Associated Clinical Trials listed on BioPortfolio]

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage ...

Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness

A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcole...

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus t...

Study to Evaluate the Effects of Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance in Adults With OSAHS Who Use nCPAP Therapy

The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep...

Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or ...

PubMed Articles [1929 Associated PubMed Articles listed on BioPortfolio]

Effects of an alternating work shift on air traffic controllers and the relationship with excessive daytime sleepiness and stress.

To evaluate symptoms of stress and excessive daytime sleepiness (EDS) in air traffic control (ATC) officers in Brazil.

Excessive Daytime Sleepiness Independently Predicts Increased Cardiovascular Risk After Myocardial Infarction.

Excessive daytime sleepiness (EDS), a common symptom among patients with sleep-disordered breathing, is closely associated with the development of cardiovascular diseases, but its long-term prognostic...

Reduced resting-state thalamostriatal functional connectivity is associated with excessive daytime sleepiness in persons with and without depressive disorders.

Excessive daytime sleepiness (EDS) is a common and significant problem encountered in affective illness, however, the biological underpinnings of EDS in persons with psychiatric disorders are not clea...

Course, risk factors, and mental health outcomes of excessive daytime sleepiness in rural Chinese adolescents: A one-year prospective study.

This study aimed to examine the one-year incidence and persistence of excessive daytime sleepiness (EDS) in rural Chinese adolescents and their risk factors. In addition, we also aimed to explore the ...

Proposal of cutoff points for pediatric daytime sleepiness scale to identify excessive daytime sleepiness.

The objective of the present study was to propose cutoff points for the Pediatric Daytime Sleepiness Scale (PDSS) through sensitivity and specificity analyses in order to identify excessive daytime sl...

Medical and Biotech [MESH] Definitions

A specific category of drugs that prevent sleepiness by specifically targeting sleep-mechanisms in the brain. They are used to treat DISORDERS OF EXCESSIVE SOMNOLENCE such as NARCOLEPSY. Note that this drug category does not include broadly-acting central nervous system stimulants such as AMPHETAMINES.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Excessive thirst manifested by excessive fluid intake. It is characteristic of many diseases such as DIABETES MELLITUS; DIABETES INSIPIDUS; and NEPHROGENIC DIABETES INSIPIDUS. The condition may be psychogenic in origin.

An excessive accumulation of iron in the body due to a greater than normal absorption of iron from the gastrointestinal tract or from parenteral injection. This may arise from idiopathic hemochromatosis, excessive iron intake, chronic alcoholism, certain types of refractory anemia, or transfusional hemosiderosis. (From Churchill's Illustrated Medical Dictionary, 1989)

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