Lung Diseases Clinical Trial
To quantify the influence of genetic and environmental factors on the development of sleep apnea.
BACKGROUND:
In 1990, there was increased recognition that obstructive sleep apnea occurs commonly and
may lead to serious adverse cardiopulmonary and psychoneurologic health effects. In subjects
with numerous and prolonged apneas, nocturnal hypoxemia and disrupted sleep may lead to
pulmonary hypertension, cor pulmonale, and excessive daytime sleepiness. Systemic
hypertension is more prevalent in subjects with obstructive sleep apnea than in the general
population. The health consequences of less severe disease have not been extensively studied
in the context of general population studies. However, snoring, a symptom related to sleep
apnea, may double the risk of ischemic heart disease. The prevalence of systemic
hypertension is higher in snorers than in nonsnorers, a finding potentially of considerable
public health concern. An increased number of deaths due to cardiovascular disease in
elderly subjects with disordered breathing during sleep also has been demonstrated.
DESIGN NARRATIVE:
The study is cross-sectional and longitudinal in design. Index cases were identified through
the Rhode Island Hospital Sleep Laboratory and controls through local industry. During home
visits, questionnaire data on symptoms, medical history, and exposures were collected and
the following measurements made: blood pressure, height, weight, and spirometry. Structural
assessment of the upper airway was made by a brief physical examination, and facial
structure was documented with a lateral photograph. Airflow, chest wall movement, oxygen
saturation, and heart rate during sleep were recorded with an ambulatory monitoring device.
Observations in the field were confirmed and extended with laboratory studies on a sample of
families who demonstrated the greatest and the least concordance for sleep-related
respiratory disturbances. These subjects had a more detailed assessment of upper airway
structure with cephalometry and posterior rhinometry, assessment of ventilatory control with
responses to chemical and resistive loading, and assessment of sleep staging with
in-hospital polysomnography. Familial correlations with and without adjustment for specific
risk factors were computed. These analyses allowed: a determination of the risk of
development of sleep apnea due to familial factors; an improved understanding of the
influences of genetic and acquired risk factors and their interactions on the development of
sleep apnea: and characterization of a generally healthy population at increased risk for
sleep apnea that were studied subsequently both longitudinally in natural history studies
and with molecular genetic markers in pedigree studies.
The study was renewed in FY 1996. The cohort was expanded by the addition of 85 families
identified through an affected proband, leading to a total of 300 families. These new cohort
members were characterized in the fashion similar to that previously used. Follow-up was
conducted on those initially recruited for apnea levels, blood pressure, body fat
distribution, cranial facial dimensions, pulmonary function, and other factors of interest.
For 450 of the individuals, follow-up extended through nine years. A nested case-control
study was also conducted that included 24-hour ambulatory blood pressure monitoring and
echocardiography. A principal analytic tool was variance component modeling.
The study was renewed in FY 2001 through March, 2005. Further studies will be conducted in
the cohort of 2,200 who had previously undergone overnight sleep studies. A total of 700
cohort members from families with sleep apnea, most of whom had a genome scan performed,
will undergo additional physiological and biochemical measurements and longitudinal
follow-up to derive detailed phenotypic characterization of sleep apnea and related
cardiovascular disease risk factors and subclinical disease. Newly available technology will
be used to quantify specific and sensitive indices of obstructive breathing parameters and
sleep fragmentation. Subjects will also undergo a biochemical profile and evaluations of
vascular functions, including assessment of novel cardiovascular disease risk factors that
may be related to sleep apnea based on common genes or their role as indices of sleep apnea
disease severity.
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Observational Model: Cohort, Time Perspective: Prospective
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