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| Studies for Veterans and their Partners |
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 Benefit/Risk |
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Risks associated with participation are minimal and generally no greater than those associated with a routine physical exam. Risks associated with each study procedure are detailed below.
Apnea-Link:
Side effects that you might experience are only related to the nasal cannula (nose tube) and tape that you will wear overnight and may include:
• Mild skin irritation around the nose and or behind the ears from the nasal cannula used with the ApneaLink device.
• Mild skin irritation around the cheeks from the tape that may be used to secure the nasal cannula to your cheeks.
• Mild irritation of the skin inside of the nose (nasal mucosa) from the tube inside your nose (nasal cannula).
• Mild skin irritation at the site of the finger sensor, similar to that you might experience when taking a Bandaid off.
Sleep Monitoring Studies: Some people may develop a skin irritation from the electrodes, tape, paste, or other sensors worn during the sleep evaluation. This kind of skin irritation quickly resolves, but if it bothers you, a steroid ointment such as the kind you buy in the drugstore can easily take care of this problem.
Actigraphy: There are no physical or health risks associated with the activity monitor. Discomfort associated with wearing the activity monitor should not be different from wearing a wristwatch.
Blood Pressure Assessments: You may experience mild discomfort when the blood pressure cuff inflates.
Diary entries and Laboratory Couple Interaction: You may experience some psychological discomfort while answering the questionnaires and diary measures about your marital interactions; however, you have the option to skip questions if you choose. Similarly, thinking and talking about problems in your relationship may make you feel uncomfortable. We will be asking you to discuss these problems as you would at home, which may cause some psychological distress.
Psychological Discomfort: Some people may feel uncomfortable answering questions of a personal nature, such as questions about mood, and you may self-disclose illegal activities. You can refuse to answer any questions or questionnaires that make you uncomfortable.
Blood Draw: There is a risk of minor bruising or skin irritation on the arm as a result of the blood draw. However, the probability of this occurring is low, and no different from a routine blood draw that you might do in your doctor’s office.
Confidentiality: An additional risk associated with this, and any other research study is the possibility of an accidental breach of confidentiality, but we will do everything possible to protect your privacy (as described in the Confidentiality section on p.8 of this document).
As with any research study, there may be adverse events or side effects that are unknown and it is possible that certain of these unknown risks could be permanent, serious or life-threatening
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