Stroke Clinical Trial
Official title:
Population-bases Study to Asses Prevalence of Sleep Disorders and Their Association With Cardiovascular Risk Factors and Diseases
Little is known on the prevalence of sleep disorders and their role in the increased prevalence of cardiovascular diseases in the developing world. We To assess the prevalence of major sleep disorders in a rural South American population, and to determine whether these conditions are associated with a poor cardiovascular health or with the occurrence of stroke or ischemic heart disease. This is a three-phase, population-based, door-to-door survey in Atahualpa. During phase I, all residents aged ≥40 years will be screened with validated Spanish versions of five questionnaires to evaluate major sleep disorders. In phase II, neurologists will examine persons suspected of having a sleep disorder and a random sample of negative individuals to assess the prevalence of these conditions and to validate the accuracy of questionnaires. In phase III, patients with a confirmed sleep disorder will undergo nocturnal polysomnography for achieving a more specific diagnosis. The occurrence of sleep disorders will be correlated with the cardiovascular health of the population as well as with the presence of stroke and ischemic heart disease. This epidemiological study may prove cost-effective in improving sleep conditions of people living in rural areas of developing countries, and may be used as a model for the evaluation of sleep disorders and their cardiovascular correlates in these populations.
For the purposes of the present part of the Atahualpa Project, field personnel were trained
to achieve expertise with the use of the screening questionnaires, and to assure uniformity
in data collection. The independent review board of Hospital-Clínica Kennedy (Guayaquil,
Ecuador) approved the study design and the informed consent form that has to be signed by
all Atahualpa residents aged ≥40 years before enrollment in the study.
Field workers will perform a census of the population to detect all Atahualpa residents aged
≥40 years (including those who were not living at the village by the time of our previous
census). Those "new" persons will be interviewed to assess their social and demographic
characteristics and to evaluate their CVH status in the same way as it was done with the
rest of the population in our most recent survey.
During the current survey, all consented persons will undergo a physical examination with
attention to the measurement of the neck circumference, as well as the evaluation of facial
characteristics relevant to the coexistence of sleep disorders, including retrognathia,
nasal septum deviation, asymmetry of the nares, and palate position. The latter will be
evaluated with the tongue resting inside the mouth (using the Friedman classification) and
categorized into four classes according to which structures are visible: Grade I allows
visualization of the entire uvula and tonsils/pillars, Grade II allows visualization of the
uvula but not the tonsils/pillars, Grade III allows visualization of the soft palate but not
the uvula, and Grade IV allows visualization of the hard palate only.
From the many questionnaires available for the detection of persons with suspected sleep
disorders, our panel agreed to choose those that have been more widely used and have shown
to be time-efficient, consistent and reliable for prediction of major sleep disorders. Field
instruments include validated Spanish versions of the insomnia severity index, the
Pittsburgh sleep quality index, the Epworth sleepiness scale, the Berlin questionnaire, and
the four minimal diagnostic criteria for restless legs syndrome.
The insomnia severity index consists of seven questions evaluating nighttime sleep
difficulties, sleep dissatisfaction, and impact of insomnia on the quality of life.
Time-frame of such evaluation is in the two weeks before the test. Each question is rated on
a five-point Likert scale ranging from 0 (not at all) to 4 (extremely) with a maximum total
score of 28. Scores from 0 to 7 mean no clinically significant insomnia, 8 to 14 mean
subthreshold insomnia, 15 to 21 mean moderate clinical insomnia, and 22 to 28 mean severe
clinical insomnia.
The Pittsburgh sleep quality index basically discriminates between "good" and "poor"
sleepers. Time-frame of such evaluation is in the month before the test. It consists of 18
questions grouped into seven component scores, each weighted on a 0 to 3 scale, for a total
score of 21, with higher scores indicating poorer sleep quality. Components include
assessment of sleep duration (total sleep time), sleep disturbances, sleep latency, day
dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and medications
needed to sleep. Total sleep time will be categorized as follows: <6 hours, 6 to 7 hours, 7
to 8 hours (referent category), 8 to 9 hours, and >9 hours. The original instrument also
includes five additional questions that should be directed to bedpartners or roommates. Such
questions will not be used in the present survey as they are not included in the scoring and
have not been validated in the Spanish language.
The Epworth sleepiness scale originally evaluates the level of a person's daytime sleepiness
based on the likelihood of dozing in eight different sedentary situations, and is used to
help diagnose hypersomnia or sleep-disordered breathing such as obstructive sleep apnea.
Each of the eight questions is rated on a four point Likert scale ranging from 0 (no chance
of falling asleep) to 3 (high chance of falling asleep) with a maximum total score of 24.
While there has been noted a considerable overlap among scores and the chance of
sleep-disordered breathing, it has been shown that a score of ≥10 highly correlates with the
presence of severe obstructive sleep apnea.
The Berlin questionnaire mainly evaluates sleep-disordered breathing (obstructive sleep
apnea), but also assess waketime sleepiness or fatigue and the presence of obesity or
arterial hypertension. It consists of 10 questions, divided in three categories. The first
five questions are included into category 1, questions from six to eight into category 2,
and question 10 in category 3 (question nine is evaluated separately). A positive response
to two questions of the first 2 categories, or to the single question of category 3, marks
the corresponding category as "positive", and positivity of two or more categories
classifies the person as at "high risk" for having obstructive sleep apnea.
The four minimal diagnostic criteria for restless legs syndrome were developed to facilitate
the recognition of this sleep-related movement disorder. All four questions must be positive
to establish the diagnosis of restless legs syndrome.
In the second phase of this epidemiological survey, a board-certified sleep neurologist
(P.R.C.) will provisionally move to Atahualpa to examine all persons who screened as
suspected cases of having a sleep disorder (in one or more of the field instruments used).
In addition, a random sample of 2% of individuals who were considered negative during the
screening phase (matched by age and gender to suspected cases) will also undergo a
specialized examination to assess possible false negative cases during the survey.
Neurologists will be blinded as to whether the individual was positive or negative during
the screening phase. All these persons will be evaluated with a unified sleep history
focusing on sleep-related symptoms, associated nocturnal symptoms, time during the sleep
period that symptoms occur, daytime functioning, sleep schedule, and the use of sleep
medications; in addition, a complete physical and neurological examination will be
performed. For persons with suspected restless legs syndrome, questions will be directed to
assess frequency and severity of symptoms, age of symptoms onset, and family history of
restless legs syndrome. In additions, mimics of this condition will be ruled out (leg
cramps, positional discomfort, fibromyalgia, arthritis, neuropathies, claudication, etc).
Correlation of the presence of specific sleep disorders with the CVH status as well as with
history of stroke or ischemic heart disease will be noted. Procedures that will be used for
evaluation of the CVH status and for the diagnosis of stroke and ischemic heart disease will
be the same that have been previously used during step one of the Atahualpa Project. In
brief, CVH status will be evaluated using the seven metrics proposed by the American Heart
Association, stroke will be diagnosed in patients who had experienced a rapidly developing
event characterized by clinical signs of focal or global disturbance of cerebral function,
lasting ≥ 24 hours, with no apparent cause other than vascular, and ischemic heart disease
will be diagnosed if the person is positive by clinical judgment or ECG findings.
In the third phase, all patients with a confirmed diagnosed of a sleep disorder will be
invited to undergo an attended nocturnal polysomnography that will objectively evaluate the
presence of sleep-disordered breathing, as well as well as other sleep disorders. EEG
activity, nocturnal movements, cardiac rhythm, and oxygen saturation. Studies will be
performed in the Community Center of The Atahualpa Project, with multiple channel
recordings, including: electroencephalogram, electro-oculogram, electromyogram on chin and
legs, electrocardiogram, body position sensors, nasal and oral airflow, oxygen saturation,
video and audio recording, and may involve trials of continuous positive airway pressure
(CPAP) or other investigations.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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