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17 Sleep Disturbance Budget Estimates The budgets below are calculated for one exposure site with 40 subjects and one control site with 40 subjects. We assume that measurement devices will be distributed on Monday and collected on Thursday or distributed on Tuesday and collected on Friday (i.e., that subjects will be investigated for 3 consecutive nights). These conditions provided, it is easy to extrapolate the study costs to larger sample sizes. For the actigraphy/ECG study (protocol #2), we made the following assumptions: ï§ With a team of 2 investigators, it will be possible to measure at 3 sites concurrently (although it is assumed that, on average, measurements will only take place at 2 sites at the same time). ï§ At each 3rd site, it will be possible to measure two subjects instead of one (which translates to an average of 1.33 subjects per site). ï§ This means it will be possible to measure 2.66 subjects per week on average (or 40 subjects in 15 weeks). ï§ As 2 weeks are needed for initial subject recruitment, this translates to roughly 1 month per 10 subjects. For the polysomnographic study (protocol #1), the following additional assumptions were made: ï§ Instead of three sites, only one site can be operated by 2 investigators concurrently. Electrodes for polysomnographic measurements have to be applied by one investigator in the evening and detached by another investigator in the morning. The latter would also backup and check the quality of last night's data. ï§ The visual scoring of the EEG is time consuming and requires one additional research assistant during the data analysis stage. ï§ Obviously, different equipment has to be purchased for the polysomnographic study, which is reflected in the budgets. To keep costs for the polysomnography study low, we only budgeted 5 instead of 6 systems. This means that at two sites two subjects could be measured concurrently, and only one subject could be measured at the third site. It is assumed that sounds and noise levels inside are measured with a class-1 sound level meter. If the airport does not collaborate, outside sounds will be continuously recorded with cheaper sound recording devices to more easily identify aircraft noise events. For the budgets below, base salaries of $100,000 (senior faculty member), $40,000 (post doctoral researcher), $30,000 (telephone recruiter), and $25,000 (research assistant), and fringe benefits of 34% were assumed. The budget estimates only reflect direct costs. Indirect costs vary from institution to institution and would need to be added. These budgets assume that both the exposure site and the control site are located in a reasonable distance from whoever is contracted to do the study. Studies involving multiple airports (across the US) would require a multi-center study or subcontracts to local universities or private companies for the field work, which would likely increase the overall cost of the study. Assuming three concurrent measurement sites, the difference in equipment and consumable costs between protocols #1 and #2 amount to (marked orange in the budget for protocol #1): $64,000 - $8,000 = $56,000 This is a one-time investment and does not depend on the sample size. If the number of concurrent measurement sites is doubled to six, this difference would increase by a factor two (i.e., 6 concurrent measurement sites: $112,000 difference). 50
From the budget calculations presented below follows that for every subject that is added to either the experimental or the control group roughly ï§ $197,547 / 80 = $2,470 for polysomnography (protocol #1) ï§ $106,213 / 80 = $1,328 for the actigraphy/ECG (protocol #2) would have to be added to the total cost of the study for each subject, and the study would have to be extended by 1 month for every 10 subjects with the assumptions stated above (i.e., 3 concurrent measurement sites). Thus, if both the exposure and the control site should consist of 60 instead of 40 subjects, the total cost would increase by 40*$2,470 = $98,800 (protocol #1) and by 40*$1,350 = $54,000 (protocol #2), and run 4 months longer. The same is true if additional airports would be investigated. Also, the need to visually score the polysomnogram requires one additional human scorer for the 8 months analysis period for 80 subjects total. 51
17.1 Budget Protocol #1 (Polysomnography) I. Preparatory Phase (Duration: 8 months) Task Description Obtain IRB approval, hire and train research assistant, perform noise calculations for subject selection, select control areas based on sociodemographic and traffic noise characteristics, prepare flyers/letters/questionnaires, acquire and test hardware Personnel Total Cost Base % effort Hours Salary Fringe Months Assistant Professor (8 months @ 20%) 17,867 $ 100000 20% 277 20,000 $ 6,800 $ 8 Post-Doc (8 months @ 100%) 35,733 $ 40000 100% 1387 40,000 $ 13,600 $ 8 Research Assistant (7 months @ 100%) 19,542 $ 25000 100% 1213 25,000 $ 8,500 $ 7 Research Assistant (2 months @ 100%) 5,583 $ 25000 100% 347 25,000 $ 8,500 $ 2 Research Assistant (2 months @ 100%) 5,583 $ 25000 100% 347 25,000 $ 8,500 $ 2 Research Assistant (2 months @ 100%) 5,583 $ 25000 100% 347 25,000 $ 8,500 $ 2 Research Assistant (2 months @ 100%) 5,583 $ 25000 100% 347 25,000 $ 8,500 $ 2 Equipment/Consumables 3 class-1 sound pressure level meters @ $4000 each 12,000 $ 2 microphone calibrators @ $500 each 1,000 $ 3 sound recording devices for outside sound measurements @ $500 each 1,500 $ 5 portable polysomnography systems including licenses @ $12,000 each 60,000 $ 2 Laptops for initializing/downloading data @ $1200 each 2,400 $ Total Cost Phase I 172,375 $ II. Data Acquisition Phase (Duration: 8 months) Task Description Recruit 80 subjects (40 exposed, 40 non-exposed), investigate 80 subjects for 3 consecutive nights each (on average) Personnel Total Cost Base % effort Hours Salary Fringe Months Assistant Professor (8 months @ 20%) 17,867 $ 100000 20% 277 20,000 $ 6,800 $ 8 Post-Doc (8 months @ 100%) 35,733 $ 40000 100% 1387 40,000 $ 13,600 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Telephone Recruiter (8 months @ 10%) 2,680 $ 30000 10% 139 3,000 $ 1,020 $ 8 Equipment/Consumables Subject reimbursement (80 subjects * 3 nights * $50) 12,000 $ Rental car (8 months @ $1000 per month) 8,000 $ Gas (8 months @ $300 per month) 2,400 $ Parking (Garage, 8 months @ $150 per month) 1,200 $ Street parking (8 months @ $100 per month) 800 $ Highway fees (4 months @ $300 per month) 1,200 $ Consumables (Postage, ECG Electrodes, EEG Electrodes) 2,000 $ Equipment maintenance/repairs/replacement 2,000 $ Total Cost Phase II 197,547 $ III. Data Analysis and Report Phase (Duration: 8 months) Task Description Analyze the data, generate a report/publications Personnel Total Cost Base % effort Hours Salary Fringe Months Assistant Professor (8 months @ 20%) 17,867 $ 100000 20% 277 20,000 $ 6,800 $ 8 Post-Doc (8 months @ 100%) 35,733 $ 40000 100% 1387 40,000 $ 13,600 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Equipment/Consumables N/A Total Cost Phase II 98,267 $ TOTAL PROJECT COST 468,188 $ 52
17.2 Budget Protocol #2 (Actigraphy/ECG) I. Preparatory Phase (Duration: 8 months) Task Description Obtainb IRB approval, hire and train research assistant, perform noise calculations for subject selection, select control areas based on sociodemographic and traffic noise characteristics, prepare flyers/letters/questionnaires, acquire and test hardware Personnel Total Cost Base % effort Hours Salary Fringe Months Assistant Professor (8 months @ 20%) 17,867 $ 100000 20% 277 20,000 $ 6,800 $ 8 Post-Doc (8 months @ 100%) 35,733 $ 40000 100% 1387 40,000 $ 13,600 $ 8 Research Assistant (7 months @ 100%) 19,542 $ 25000 100% 1213 25,000 $ 8,500 $ 7 Equipment/Consumables 3 class-1 sound pressure level meters @ $4000 each 12,000 $ 2 microphone calibrators @ $500 each 1,000 $ 3 sound recording devices for outside sound measurements @ $500 each 1,500 $ 6 heart rate and actigraphy systems including software licenses @ $1000 each 6,000 $ 3 temperature, humidity, light intensity measurement systems @ $400 each 1,200 $ 2 Laptops for initializing/downloading data @ $1200 each 2,400 $ Total Cost Phase I 97,242 $ II. Data Acquisition Phase (Duration: 8 months) Task Description Recruit 80 subjects (40 exposed, 40 non-exposed), investigate 80 subjects for 3 consecutive nights each (on average) Personnel Total Cost Base % effort Hours Salary Fringe Months Assistant Professor (8 months @ 20%) 17,867 $ 100000 20% 277 20,000 $ 6,800 $ 8 Post-Doc (8 months @ 100%) 35,733 $ 40000 100% 1387 40,000 $ 13,600 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Telephone Recruiter (8 months @ 10%) 2,680 $ 30000 10% 139 3,000 $ 1,020 $ 8 Equipment/Consumables Subject reimbursement (80 subjects * 3 nights * $50) 12,000 $ Rental car (8 months @ $1000 per month) 8,000 $ Gas (8 months @ $300 per month) 2,400 $ Parking ( Garage, 8 months @ $150 per month) 1,200 $ Street parking (8 months @ $100 per month) 800 $ Highway fees (4 months @ $300 per month) 1,200 $ Consumables (Postage, ECG Electrodes) 1,000 $ Equipment maintenance/repairs/replacement 1,000 $ Total Cost Phase II 106,213 $ III. Data Analysis and Report Phase (Duration: 8 months) Task Description Analyze the data, generate a report/publications Personnel Total Cost Base % effort Hours Salary Fringe Months Assistant Professor (8 months @ 20%) 17,867 $ 100000 20% 277 20,000 $ 6,800 $ 8 Post-Doc (8 months @ 100%) 35,733 $ 40000 100% 1387 40,000 $ 13,600 $ 8 Research Assistant (8 months @ 100%) 22,333 $ 25000 100% 1387 25,000 $ 8,500 $ 8 Equipment/Consumables N/A Total Cost Phase II 75,933 $ TOTAL PROJECT COST 279,388 $ 53
