Lung Diseases Clinical Trial
To determine the degree to which neuro-psychological performance and general health status and function may be impaired in subjects with mild and moderate degrees of sleep-related respiratory disturbances (SRRD), as compared to subjects with minimal apneic activity. Also, to assess the degree to which improvement may occur following specific treatment.
BACKGROUND:
The study was a subproject in a Specialized Center of Research in the Cardiopulmonary
Disorders of Sleep. Frequent sleep-related respiratory disturbances (SRRD) have been
recognized to occur in as many as 70 percent of elderly and 15 percent of middle-aged
subjects. Although it is widely agreed that subjects with obvious daytime sleepiness that
occurs in association with severe obstructive sleep apnea (Respiratory disturbance indices
(RDI) >30) benefit from treatment of their sleep disorders; there is no consensus (and a
paucity of data) regarding treatment benefits in subjects with a less profound disorder.
Rational utilization of health care resources for diagnosis and treatment of sleep apnea
requires assessment of whether adverse health effects occur as a consequence of mild or
moderate levels of SRRD, and whether any such health effects may be reversible with
treatment.
DESIGN NARRATIVE:
The neuropsychological performance, sleepiness and general functional status were evaluated
in 330 subjects, including subjects with little apneic activity (RDI<5), mild activity (RDI
5-14), and moderate activity (RDI 15-25). Of these subjects, 75 percent were selected from a
clinic-based sample, and 25 percent were recruited from an ongoing population-based study.
150 subjects with mild and moderate activity were randomized to receive 'conservative'
medical therapy (CMT) or CMT plus nasal continuous positive air pressure (CPAP) therapy.
Simple statistics, as well as multivariate techniques, were used to determine the
relationship between SRRD (and associated hypoxemia, sleep fragmentation, and physiological
sleepiness) to: a) intellectual abilities, attention and vigilance, psychomotor performance,
learning and memory, and executive functions, and b) to general health status and function.
Potential benefits of treatment specific for sleep apnea in subjects with mild and moderate
SRRD were also determined after two months of CPAP therapy.
The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).
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