|
|
| Studies for Veterans and their Partners |
| |
 Military Couples Sleep Study |
| |
| |
Location: 3811 O’Hara St., Pittsburgh, PA 15213. Parking is provided.
Step 1: You will meet with a study staff member and go over the study in detail, and will begin to complete study-related interviews and questionnaires. You will go home with an in-home apnea screening device for you to use overnight which will assess for any sleep disorders. You will then individually visit our offices to meet with a study clinician. Each of these visits will take approximately 3 hours to complete.
Step 2: 10 Day Home Study: Over a 10-day period, we will ask you to wear a watch that will record your 10-day activity level, as well as provide you with a Palm Pilot to record daily events. On night 1 and night 2 study staff will arrive in your home to deliver and set up sleep monitoring equipment. On night 2, we will also provide you with supplies to collect overnight urine samples. At a convenient time between nights 3 and 10, you will wear a blood pressure monitor for 48 consecutive hours. The blood pressure monitors are portable devices which can be hidden under clothing.
Step 3: You will be asked to come back to our offices in the morning to provide a fasting blood draw, and you will be asked to engage in 2 videotaped discussions with your partner. This visit will last approximately 3 hours.
Final Payment: Up To $400
**Study staff will work with you and your spouse to schedule all study procedures at a time that is convenient for the both of you; however, there are certain procedures that must occur at certain times and in a certain order.
**All information collected throughout the research study will remain confidential. No part of your participation in our research study will enter your military or medical records.
If you are interested in participating and/or learning more,
Please contact Tyler Conrad @ 412-864-1179 or conradt@upmc.edu
|
| |
| |
to top |
|
|
| |
| Benefit/Risk |
| |
| |
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
|
| |
| |
to top |
|
|
| |
| Timeline |
| |
| |
The total duration of the study is designed to accommodate participant's schedules, laboratory, and study staff schedules.
Participation ranges from 2 weeks following the consent phase of the study and up to 1.5 months, depending on scheduling.
|
| |
| |
to top |
|
|
| |
| Confidentiality |
| |
| |
Any information about you obtained from this research will be kept as confidential (private) as possible. All data obtained from this research, including the video recordings, will be kept in a locked file cabinet and on secure password-protected computer databases. Your identity on these records will be indicated by a random identification number rather than by your name, and the information linking these case numbers with your identity will be kept separate from the research records. You will not be identified by name in any publication of research results unless you sign a separate form giving permission (release).
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Heart, Blood, and Lung, effective as of 9/21/11. Under the protection of the approved Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you.
|
| |
| |
to top |
|
|
| |
| |
|
