CEP-10953 in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome

04:49 EDT 20th August 2014 | BioPortfolio

Summary

The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Sleep Apnea, Obstructive

Intervention

CEP-10953

Status

Completed

Source

Cephalon

Results (where available)

View Results

Links

Clinical Trials [891 Associated Clinical Trials listed on BioPortfolio]

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months...

Vasoactive Hormones and Oxygen Saturation During Apneic Events in Patients With Obstructive Sleep Apnea

The mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified. We hypothesize that patients with obstructive sleep apnea have an abno...

Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea is a problem for a large number of children and can result in problems with thinking patterns, behaviors and sleep if left untreated. Little is known about how posi...

Autonomic Function in Obstructive Sleep Apnea

The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.

Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery

The study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting for total knee or total hip arthroplasty is higher than generally suspected. The study will i...

PubMed Articles [1998 Associated PubMed Articles listed on BioPortfolio]

Cardiovascular Morbidity and Obstructive Sleep Apnea.

Obstructive sleep apnea, a relatively common disorder in adults, is characterized by sleep-related periodic breathing, upper-airway obstruction and asphyxia, sleep disruption, and acute autonomic, art...

Headache in sleep apnea syndrome: Epidemiology and pathophysiology.

This review investigates the relation between obstructive sleep apnea and sleep apnea headache, migraine and tension-type headache. Focus is made on studies from the general population with interviews...

A case of obstructive sleep apnea and assessments of fitness for work.

Obstructive sleep apnea is a common sleep disorder that can cause excessive daytime sleepiness and impairment of cognition. These symptoms may lead to the occurrence of occupational accidents in worke...

Recognizing pediatric sleep apnea.

: Obstructive sleep apnea is a common condition in childhood and has a significant impact on health, learning, academic performance, and quality of life. The purpose of this article is to review the e...

Mapping gray matter reductions in obstructive sleep apnea: an activation likelihood estimation meta-analysis.

The authors reviewed the literature on the use of voxel-based morphometry (VBM) in obstructive sleep apnea (OSA) magnetic resonance imaging (MRI) studies via the use of a meta-analysis of neuroimaging...

Medical and Biotech [MESH] Definitions

A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. This condition may be idiopathic (primary) or associated with lower brain stem lesions; chronic obstructive pulmonary disease (LUNG DISEASES, OBSTRUCTIVE); HEART FAILURE, CONGESTIVE; medication effect; and other conditions. Sleep maintenance is impaired, resulting in daytime hypersomnolence. Primary central sleep apnea is frequently associated with obstructive sleep apnea. When both forms are present the condition is referred to as mixed sleep apnea (see SLEEP APNEA SYNDROMES). (Adams et al., Principles of Neurology, 6th ed, p395; Neurol Clin 1996;14(3):611-28)

Disorders characterized by multiple cessations of respirations during sleep that induce partial arousals and interfere with the maintenance of sleep. Sleep apnea syndromes are divided into central (see SLEEP APNEA, CENTRAL), obstructive (see SLEEP APNEA, OBSTRUCTIVE), and mixed central-obstructive types.

A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395)

Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)

HYPOVENTILATION syndrome in very obese persons with excessive ADIPOSE TISSUE around the ABDOMEN and DIAPHRAGM. It is characterized by diminished to absent ventilatory chemoresponsiveness; chronic HYPOXIA; HYPERCAPNIA; POLYCYTHEMIA; and long periods of sleep during day and night (HYPERSOMNOLENCE). It is a condition often related to OBSTRUCTIVE SLEEP APNEA but can occur separately.

More From BioPortfolio on "CEP-10953 in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome"

Search BioPortfolio:
Advertisement
Advertisement