BF2.649 in Patients With Obstructive Sleep Apnea (OSA), Still Complaining of Excessive Daytime Sleepiness (EDS) and Refusing to be Treated by Continuous Positive Airway Pressure (CPAP)
Summary
The purpose of this study is to confirm whether BF2.649 is effective to decrease the excessive daytime sleepiness in patients with obstructive sleep apnea.
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
Obstructive Sleep Apnea
Intervention
BF2.649, Placebo
Location
Centre Hospitalier Universitaire de Grenoble
Grenoble
France
38043
Status
Not yet recruiting
Source
Bioprojet
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01072968
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sleep Apnea, Central
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)
Sleep Apnea Syndromes
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.
Sleep Apnea, Obstructive
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)
Sleep Disorders, Intrinsic
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)
Obesity Hypoventilation Syndrome
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.
Clinical Trials
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.
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.
Sleep Apnea: Mechanism and Cerebrovascular Consequences
This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3...
PubMed Articles
A Case of Positional Central Sleep Apnea.
Obstructive sleep apnea results from structural compromise of the upper airway and decreased muscle tone during sleep. Central sleep apnea is usually due to instability of the feedback mechanism of th...
By the current definition, complex sleep apnea (CompSA) refers to the emergence of central sleep apnea (CSA) during the treatment of obstructive sleep apnea (OSA) with continuous positive airway press...
In-home, self-assembled sleep studies are useful in diagnosing sleep apnea in the elderly.
Obstructive sleep apnea (OSA) is common and treatable among the elderly. Yet, few older adults seek evaluation for OSA at sleep disorders centers. The authors assessed the feasibility of a two-stage s...
Impact of untreated sleep apnea on prognosis of patients with congestive heart failure.
128 congestive heart failure (CHF) patients with a median age of 55 years and median left ventricular ejection fraction of 35.4% were followed up for a median period of 35 months. 23 (18%) had no slee...
To determine associations between obstructive sleep apnea (OSA) and neurocognitive performance in a large cohort of adults.