Obesity Clinical Trial
To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).
BACKGROUND:
The study utilized an extremely rich source of data collected on the Wisconsin Sleep Cohort,
one of the largest cohort studies of SDB and one with the longest periods of follow-up, to
address a broad array of questions related to the pathogenesis and risk of SDB in the
general community. The data-set was obtained between 1988 and 1998 in a population of 1400
workers age 30 to 60 years, including an overnight sleep polysomnographic in-lab study
conducted on two occasions over an eight year period. The dataset contained a computerized
analysis of over 300,000 apneas and hypopneas in this non-clinical population.
Although strong associations have been demonstrated between sleep disordered breathing and
cardiovascular diseases, much is not known regarding the mechanisms by which SDB produces
blood pressure changes and increases morbidity. Further analysis of the polysomnography and
blood pressure data could yield important insights into the physiologic events responsible
for cardiovascular morbidity. Such information could then be used to develop diagnostic
tests that identify those people at highest risk and thus who might especially benefit from
intervention. This would be of potentially great public health importance, given the
prevalence of SDB and the availability of treatments for SDB.
DESIGN NARRATIVE:
The investigators used the computerized database of the Wisconsin Sleep Cohort to answer the
following specific questions. What were the physiologic characteristics of SDB events in the
non-clinical population in terms of severity, high airway resistance, obstructive and
central components and associated after-effects on EEG arousal and ventilatory overshoots?
Did these important elements of the SDB event change as SDB progressed over time? Did the
ventilatory or cardiovascular consequences of apnea or hypopnea and its immediate aftermath
determine the likelihood of subsequent sleep-disordered breathing events? 2. What were the
immediate and long-term cardiovascular consequences of sleep-disordered breathing events;
what characteristics of these SDB events (such as oxygen desaturation, arousal, ventilatory
overshoot airway resistance, etc.) determined the cardiovascular responses and consequences?
3. What was the effect of aging on SDB and its sequelae as studied in the truly healthy
elderly? 4. What role did anatomical characteristics of the upper airway play in determining
the frequency and severity and type of sleep-disordered breathing? Did these anatomical
determinants differ in the general non-clinical population versus the obstructive sleep
apnea (OSA) population? ... in the obese versus the non-obese?
Organization responded that the study is non-FDAAA applicable and they do not accept
transfer to their organization.
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