October 31, 1995SHHS OPERATIONS MANUALAPPENDICES Page - 1
A.1Comparability Committee Evaluation of A-Variables by Parent
Cohort
Following is the Comparability Committee's evaluation of A-variables by parent cohort.
(PLEASE SEE THE COMPARABILITY STUDY DOCUMENT ELSEWHERE ON THIS WEB PAGE.)
THIS PAGE IS BLANK.
A.2Example Documents for Recruitment and Retention
This section contains examples of documents that cohorts may wish to use, or adapt to their needs, for the recruitment and retention processes.
A.2.1Initial Letter to Accompany the Sleep Habits Questionnaire
Dear (your name) Study Participant John Jones,
The attached questionnaire has been designed to explore your sleep and other related health habits. This is part of a new research effort (The SLEEP HEART HEALTH STUDY) which is being offered to members of the (your cohort name) study as well as to members of four other major studies throughout the country.
Recent research findings have suggested that there may be links among high blood pressure, heart disease and breathing disorders during sleep. There are many important questions about the ways in which these health problems could affect us. For instance, we do not yet know whether sleep problems are risk factors for heart disease in the same way that high cholesterol might be. A better understanding of this will help us determine how to prevent heart disease and improve overall health.
Your name was selected, because you have been a valuable member of (name). We hope you will decide to help us and take a few minutes to complete the questionnaire. Your participation in this new research effort will help us learn how frequently sleep problems occur and why some people are at greater risk of developing breathing difficulties during sleep and heart disease.
If you agree to complete the questionnaire, you also will become a member of the SLEEP HEART HEALTH STUDY. Your answers are completely confidential. Only your ( ID, study number) will appear on study documents.
Completing this questionnaire does not commit you to any other involvement. However, some participants will be invited to participate in a sleep study to be completed in their home. If you are selected, additional information regarding that study will be sent to you.
Please remember that completing this questionnaire in no way obligates you to additional participation. However, it is very important to have as many completed questionnaires as possible. We are interested in your answers even if you have no sleep problems.
Studies like the SHHS and (parent study name) have helped us make significant progress toward reducing heart disease. We appreciate your cooperation and look forward to hearing from you if questions arise.
Sincerely,
PI and telephone contact person with number
A.2.2SHHS Brochure
This brochure is modeled after the University of Wisconsin Study's three-fold, double-sided brochure. Outer side shows SHHS name and logo along with parent study name and investigators names and telephone numbers.
Inner informational side (example follows):
What is the purpose of the Sleep Heart Health Study?
The Sleep Heart Health Study (called SHHS) will obtain information on the sleep and health habits of people across the country to determine how sleep and other health habits may affect heart disease. To do this most effectively, we have chosen to work with 6 centers already examining heart and lung disease and your health. The (...) study is fortunate to be one of those chosen.
Why is the SHHS important?
Recent research findings have suggested a link between breathing disorders during sleep and heart disease. There are times during sleep in which breathing may stop for brief seconds. Persons who have a high number of these may be given the diagnosis of “sleep apnea.” We believe that this disorder and a milder form called “sleep disordered breathing” may be more common than previously thought and may therefore be an important link to heart disease.The only way to truly know how common these sleep problems are and how they may be related to heart disease is to study the occurrence in a large group of people. The (name of your cohort) is such a group for whom we already have important related information.
What will the findings show?
We expect to learn just how common breathing disorders are during sleep. Additionally, we expect to see what type of person is most likely to have the problem. Furthermore, we expect to learn whether sleep problems in general lead to other health problems during the day, such as extreme sleepiness or heart disease.
How will I benefit?
A sleep study is very interesting. Experts will evaluate your sleep, determining how much time you slept, the type of sleep you had and how your heart and breathing respond during sleep. This is important information which can form a normal baseline for you or may reveal a sleep problem in very early stages which could be easily corrected. You will receive a report of your sleep study. If any abnormality is found, we will share that with you and any doctor you choose. Additionally, you will learn a great deal about your sleep habits and the best way to improve them.
THERE IS NO COST FOR THIS STUDY, even though this type of test could cost $500-$1500 if taken privately. For the many people who need this test, the waiting time is usually several months.
Beyond any personal benefit, your help is important to understand how sleep may affect heart disease. Our findings may improve your health or the health of someone you love.
What is an overnight study like?
If you agree to participate in the home sleep study, a specially trained team of technicians will come to your home on a convenient evening between 8 and 10pm. Then, sensors will be painlessly applied to your skin and scalp. Two sensors will be attached to your head with water soluble paste. Four others will be attached to your face to monitor eye movements and chin muscle tone. Two will be attached to your chest, much like a cardiogram. These will measure heart rate and breathing. A thin plastic tube will be taped under your nose to monitor breathing. Finally, a sensor will be taped to your finger to measure the oxygen in your blood.
The signals recorded by the sensors can be “read” by a sleep specialist. Information from the signals tell us about the type of sleep and breathing you are having. Please note:
NO ELECTRICITY OR ENERGY IS GIVEN TO YOU!
THE TEST IS COMPLETELY PAINLESS
(We have included a picture of one of our staff wearing the sleep monitoring equipment so you can have an idea of how you will look!)
Despite all these attachments, most everyone sleeps comfortably. You are able to move around comfortably. The technician will show you how to separate from the recorder if you need to get up during the night. Your night can continue in the usual manner. The equipment will be picked up at a pre-arranged time in the morning.
What else will be done during the study?
Prior to attaching the sensors, the technicians will take your blood pressure and help you complete several brief questionnaires. There will be one questionnaire which will be left with you in the event you wish to tell us something privately.
Additionally, there may be other small studies which you may be invited to join. These may involve tests of memory, MRI or xray studies of head size. As always you are under no obligation to join these studies.
How do I schedule a study?
[This is site specific.]
If you wish to participate please call (....at ....).
A convenient time will be chosen for your study. Since we only need to test you during your normal sleep hours, the study should not interfere with your work schedule.
You will be called several days prior to the study to review the plans and see whether there have been any major changes in your health. As you can imagine, to accommodate the large group of participants, our schedules are important. We appreciate any notice you can give us regarding necessary changes in your appointment once it is scheduled.
What happens afterward?
On the morning following the sleep test, a technician will pick up the equipment at your home. You will be sent a report of your study following its review. If problems arise, we will contact you within one week.
October 31, 1995SHHS OPERATIONS MANUALAPPENDICES Page - 1
THIS PAGE IS BLANK.
October 31, 1995SHHS OPERATIONS MANUALAPPENDICES Page - 1
A.2.3Letter to Invite Individual to Participate in Home Sleep Study
Dear .....
Thank you for your participation in the SHHS. Information from the sleep habits questionnaire is being studied now. We will send you results of that part of the study as soon as they are available.
Now, we would like to invite you to participate in the home sleep study. If you recall, we will be studying 6000 people across 6 centers to examine sleep and breathing across the night.
We expect that results of this landmark study will be presented and referred to throughout the world. This is a major effort and YOU are a very important part. Without people like you, we would still know very little about sleep and breathing.
Please consider participating in the next phase of our study. I have enclosed a pamphlet to answer questions regarding the study. Feel free to give (name...) a call if additional questions occur.
Sincerely,
Study PI and Coordinator
A.2.4Tidbits for Entry into a Newsletter “Did You Know” Series
SNORING
Did you know that about half the adult population snores during sleep?
Snoring is the result of air passing through a restricted or blocked area. Snoring, then, is much like the sound one gets from a wind instrument when different reeds are applied.
In some cases the blockage in the air passage is due to something in the way such as enlarged tonsils or adenoids.
In other cases, normal throat tissue may loose tone as we age or when we sleep and sag into the air passage. This is particularly true when we lie down on our backs. Sometimes even turning on one's side clears this tissue out of the air passage and snoring stops.
APNEA ( May not be appropriate until the end of the study.)
Did you know that 5-10 % of people may have a complete blockage of the air passages during sleep? The blockage is usually cleared with a loud snort or gasp which is intermittent during the night. If the blockage of air is complete, we call that apnea.
Apnea stands for the cessation or stoppage of the flow of air. The stoppage may only last seconds but may reoccur every sleeping minute. To end each one of these episodes,the brain wakes up for seconds and breathing returns. Once sleep reoccurs, the blockage returns. This cycle can go on every night and all night long!
Patients with this disorder are very sleepy during the day, probably because their sleep is so disrupted. Also with each apnea, oxygen levels dip, sometimes quite a bit. In this case the person may also suffer from a lack of adequate oxygen.
Some of the effects are daytime sleepiness, loss of memory, loss of the ability to concentrate, feelings of depression and irritability.
SLEEP HYGIENE
Did you know that there are simple behavioral changes that you can make to improve your sleep?
1.Wake up at the same time every day. This will help reinforce/reset your biological clock.
2.Settle problems and concerns earlier in the day. Finding a quiet time in the late afternoon when you can focus on solutions for your problems will help reduce the stress related to them. Once stress is reduced, the sleep system can respond.
3.Avoid alcohol, nicotine and caffeine late in the day. Alcohol tends to disrupt the natural flow of sleep across the night. Nicotine and caffeine are stimulating and may not allow the sleep system to respond properly.
4.Make your sleep area as safe and secure from noise and interruption as possible. Even though we don't believe it, radio and TV or conversation noises tend to disrupt rather than lull sleep.
5.Develop some late afternoon exercise time. Even low impact aerobics such as walking or swimming is helpful. Along with reducing stress, the activity increases body heat which tends to deepen sleep.
SLEEP DEPRIVATION
Did you know that a large segment of our society is sleep deprived. Sleep loss is accumulative. Even though we attempt to make it up over the weekend, by midweek we are once again dangerously sleepy. Sleepy people suffer a number of symptoms, such as, slowed reaction time, loss of attention, actual short microsleeps (even behind the wheel of a car). They tend to get stuck on simple ideas and have problems problem-solving and making proper decisions.
The best way to test how much sleep you need is to allow yourself to sleep as long as possible on vacation. After a few days of make-up time, your normal sleep need will emerge. The likelihood is that you need between 7-9 hours of sleep each day to feel fully rested.
DREAM SLEEP
Did you know that sleep is an important part of our 24-hour day? Sleep can be a very active time for our brains. During sleep, we cycle in and out of dream sleep, called rapid-eye-movement or REM sleep at least 4 times. These cycles begin after about 90 minutes and occur every 90 minutes thereafter. During this time our brains appear to be as active as they are in wake. We know from our own experience and others reports, that our thoughts may be very confused and our experiences very vivid. We think this is so because, during this state, random areas in the brain are activated and the thinking part of our brain tries to make a sensible story from these random thoughts.
Fortunately, our bodies are almost completely paralyzed and unable to respond during this time. We can't, for instance, charge off on a big white horse or act out other aspects of our dreams.
Researchers do not know why we dream but many believe it is a way that the brain sorts out information and settles new memories into place. Sleep is a fascinating journey.
ANY OTHERS?
There have been suggestions of other rewards/incentives such as coffee mugs, refrigerator magnets, wallet-sized business cards, etc., all bearing the study logo and local telephone numbers. This could become a meaningful budget problem.
A.2.5Follow-up Questionnaire for Home Study
Dear ....
Thank you for participating in this phase of the SHHS study. We realize that allowing someone into your home in the evening may be inconvenient. For that reason, we want to be sure that our service met with your expectations.
(name of coordinator) will call you over the next few days to thank you for your participation and check if there were any problems. However, we wanted to give you an opportunity to confidentially let us know if any serious problems arose during your testing.
Will you read over this survey? If you wish to respond to any of the items, please seal the completed survey in the self addressed envelop and return it to us. In this way, your privacy is protected and we will be able to work toward improving our service.
Answer format Yes/No
1.Were we helpful in scheduling you?
2.Did we answer your questions completely?
3.Was our schedule convenient for you?
4.Did our technicians arrive on schedule?
5.Were they polite and comfortable to be near?
6.Was the equipment clean?
7.Did you find the equipment difficult to use?
8.How comfortable was the equipment to wear?
Please add any other comments which you think may be helpful to us.
Thank you again.
(Study coordinator's name)
A.3Equipment Evaluation
The process of choosing sleep monitoring equipment involved: (1) defining the procedures and signals needed to most appropriately address the SHHS hypotheses; (2) evaluating the feasibility and trade-offs of alternative approaches for collecting these data (including a feasibility study); and (3) soliciting input from industry, including participation in local (Cleveland) and central (Steering Committee) demonstrations of equipment.
1.Defining the needs
The Polysomnography (PSG) Committee, composed of William Bonekat (Sacramento), Paul Enright (Tucson), Daniel Gottlied (Framingham), Conrad Iber (Minnesota), Mark Sanders (Pittsburgh), Philip Smith (Baltimore) and Susan Redline (Chair, Reading Center), met regularly by conference call and at Steering Committee meetings. (PSG member David Rapoport, New York, was not involved in these deliberations.) Based on data from the literature and personal experience, the following measurements were identified as needed for collection of the minimally necessary data for assessment of sleep disordered breathing and its relationship to cardiovascular morbidity: