Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
Summary
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.
Description
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Obstructive Sleep Apnea
Intervention
ApneaLink Sleep Screener
Location
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
United States
15213
Status
Completed
Source
ResMed
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00354614
- 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 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)
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 Stages
Periods of sleep manifested by changes in EEG activity and certain behavioral correlates; includes Stage 1: sleep onset, drowsy sleep; Stage 2: light sleep; Stages 3 and 4: delta sleep, light sleep, deep sleep, telencephalic sleep.
Clinical Trials
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PubMed Articles
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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...
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...
STUDY OBJECTIVES: To evaluate the sensitivity and specificity of a portable single-channel (intra-nasal pressure) sleep apnea device (ApneaLink) in both the laboratory and at home for assessment of sl...
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...