Obstructive Sleep Apnea Clinical Trial
Official title:
A Prospective Study to Determine the Effect of Positive Airway Pressure on Heart Rate Variability in Individuals With Obstructive Sleep Apnea
This study is designed to determine the effect of continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) on heart rate variability (HRV) in patients with obstructive sleep apnea (OSA).
Visit 1: You will come to the Diabetes and Metabolic Research Center having refrained from
taking your routine medications and having not eaten in the last 8 hours, avoided using
caffeine-containing beverages and tobacco products in the last 10 hours, and having had no
alcoholic beverages in the last 24 hours. In addition, you should refrain from taking any
nonprescription drugs and avoid engaging in any vigorous exercise for 48 hours before
testing.
For those individuals who have diabetes, a letter or direct verbal permission will be
obtained, prior to coming to this study visit, from your eye doctor indicating that you can
take part in one of the tests listed below. During this visit, an electrocardiogram (EKG,
usual heart rhythm test performed in a doctor's office) will be performed. Your heart rate
will also be measured for six minutes with an EKG machine while breathing as deeply as
possible. This test, which will be performed twice, will tell whether or not the nerves that
go to the heart are normal. You will be asked to blow into a plastic tube for 15 seconds
(this is the test for which we will obtain the eye doctor's permission for individuals with
diabetes). Your heart rate will be measured during and for 60 seconds after you have
finished blowing. This test, which will be performed twice, will tell if the nerves that go
to blood vessels are normal. Your blood pressure will be measured four times, one minute
apart, while you are lying down. You will then be asked to stand up and your blood pressure
will again be measured four more times, each time one minute apart. Change in your heart
rate will also be determined as you go from lying down to standing. All individuals will
have a fingerstick blood sugar level performed prior to the performance of the tests
describe above.
You will have about 2 tablespoons of blood drawn. This blood will be stored (frozen) in case
possible risk factors of reduced heart rate variability are discovered in the future. A
random urine sample will be stored (frozen) for potential examination for microalbuminuria
(protein in the urine) or other possible risk factors. At this visit, we will give you a
container with instructions for collecting urine for 24-hours. You will also be given some
dietary suggestions (e.g., eating a liberal salt diet) that we would like you to follow for
3-days prior to the 24-hour collection of urine. For individuals with diabetes, a small
portion of blood will be checked to determine your blood sugar control level.
Standard medical history questions will be asked during this visit along with questions that
assess the likelihood of you falling asleep in various situations. Your medical records from
your pulmonary doctor will be reviewed for information about the results of the sleep study
you had that determined you have a sleep disorder. You will be asked to keep a diary
everyday, for the first six weeks, of how many hours per night you use the treatment for
your sleep disorder. This visit will last approximately 1-1 ½ hours.
Visit 2: Within 1-48 hours of completion of the 24-hour urine collection and before you
begin treatment for your sleep disorder, you will need to bring the urine specimen to the
Diabetes and Metabolic Research Center. A part of this urine will be stored (frozen) for
possible testing of a hormone called aldosterone, substances filtered by the kidneys (salt
and creatinine), and other potential risk factors. Also at this visit, about 2 tablespoons
of blood will be drawn and stored for potential testing of a protein in the blood called
renin. You should continue the dietary suggestions (e.g., liberal salt diet) given for the
collection of the 24-hour urine until the blood is collected. A part of the blood drawn
during this visit will also be stored (frozen) in case potential risk factors of heart rate
variability are discovered in the future. This visit will last approximately 15 minutes.
Since some drugs can affect how much your heart speeds up and slows down, if your doctor
adds a new drug or changes the dosage of any current drugs you may not be able to continue
in this study. Please inform a member of the research staff when your doctor makes any
change in your medications.
Before coming to the Diabetes and Metabolic Research Center for visit 3, we will need to
determine if you have used your device for the treatment of your sleep disorder enough
during the six week period. Therefore, a member of the research staff will call you on a
weekly basis to ask you to tell us the information that you have recorded in your diary with
regard to how often you used the device for the treatment of your sleep disorder.
Visit 3 (approximately six weeks after you begin treatment for your sleep disorder): If you
have used the device that is being used to treat your sleep disorder enough, you will be
invited to come for visit 3. All of the tests performed during the first visit will be
performed again during visit 3. Thus, you will need to follow the same instructions about
food, medicine, and exercise as described under visit 1 before coming to visit 3. You will
again have a fingerstick blood sugar level performed. In addition, about 2 tablespoons of
blood will be drawn. This blood and a random urine sample will be stored (frozen) in case
possible risk factors of reduced heart rate variability are discovered in the future and in
case these factors need to be examined before and after treatment for a sleep disorder. The
same questions asked with regard to the likelihood of you falling asleep in various
situations will be asked. This visit will last approximately 1-1 ½ hours.
Visit 4 (approximately 18-months after you begin treatment for your sleep disorder): If you
continue to use the device that is being used to treat your sleep disorder for 18-months,
you will be invited to come for visit 4. All of the tests performed during the first visit
will be performed again during visit 4. Thus, you will need to follow the same instructions
about food, medicine, and exercise as described under visit 1 before coming to visit 4. You
will again have a fingerstick blood sugar level performed. In addition, about 2 tablespoons
of blood will be drawn. This blood and a random urine sample will be stored (frozen) in case
possible risk factors of reduced heart rate variability are discovered in the future and in
case these factors need to be examined before and after treatment for a sleep disorder. For
individuals with diabetes, a small portion of blood will be checked to determine your blood
sugar control level. The same questions asked with regard to the likelihood of you falling
asleep in various situations will be asked again. This visit will last approximately 1-1 ½
hours.
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Observational Model: Case-Only, Time Perspective: Prospective
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