R01 Study Flowchart

Owned by Fernando Martinez
Last updated: Oct 19, 2022
6 min read

R01 Flowchart

1. Recruitment and Screening

  • Eligible Subjects are: OSA Untreated, OSA CPAP, Healthy Control:

    • Subjects will be asked to complete all or some of the following procedures:

      • Physiology

      • Functional MRI (may be excluded)

      • Sleep study or Home Sleep study confirming OSA diagnosis

      • Questionnaires: Everyday (State), Baseline (Trait), Symptom Timeline, and Calgary (only for OSA subjects) & MoCA assessments

      • Stress reduction or IMT interventions:

        • Ideal Subjects for the IMT procedure include: individuals with high blood pressure, cognitive/memory problems, not physically active, unmotivated/lack of motivation/difficulty sticking to things, obese/overweight, moderate-to-high severity of sleep apnea, and female (preference for females > males). IMT study information can be found HERE

  • Screening

    • Schedule a time with the subject to provide more study information and perform the screening once you have answered any questions or concerns they might have.

    • Use the appropriate phone screen to confirm eligibility: OSA phone screen for confirmed OSA participants, and Control phone screen for Control AND Suspected OSA. Phone screens can be found HERE

  • Post-Screening

    • After completing the phone screen, confirm a preferred email address with the subject and send them the Population Survey and Participant Bill of Rights. A sample email template can be found HERE

    • Review the Population Survey on Qualtrics once the subject has completed the survey to ensure continued eligibility.

2. Sleep Study

  • Sleep Study

    • After the subject has completed the Population survey, they are now enrolled in the study.

    • OSA subjects should be asked to provide a copy of their most recent sleep study to confirm OSA status. Study results should be recorded in the Study Lab Book and the Subject and Data tracking sheet (include severity).

    • Control and Suspected OSA will complete a 2-night home sleep study.

      • To enroll the subject in the Watermark/Sleepmed home sleep diagnostic service, obtain the following information from the participants:

        • Preferred shipping address for the kit

        • Date of Birth

        • Preferred phone number where Watermark representative can reach them

      • Email the ARES questionnaire link to the subject and ask them to complete this questionnaire before sending the enrollment form to Watermark. A sample template can be found HERE

      • Once the patient has completed the ARES questionnaire on Qualtrics, it should be sent to Watermark along with the completed enrollment form.

        • Enrollment forms can be emailed to mailtopatient@watermarkmedical.com or faxed to (877) 387-6715. Fax machines are located in the 4th and 2nd floor copy rooms of the Factor Building.

    • You can track the progress of the sleep study and download a copy of the final report through the Watermark Medical Portal.

      • If you do not have an account, request an account and linking it to Ravi Aysola (interpreting Physician) & Practice Name (UCLA OSA Brain Research). The request should be made to the account representative, Susan Parson (sparsons@sleepmedinc.com).

    • Upload a copy of the completed sleep report with any identifiers removed into their subject folder on the W-drive (Raw Data). Store the hard copy of the report in the subject folder in the filing cabinet in Factor 4-230. Instructions on creating a new study folder on the W-drive can be found HERE.

    • The subject will be compensated $50 for completing the home sleep study. In order to reduce the number of payment requests, you can let the subject know that you will bundle the sleep study payment with the payment for the other procedures (physiology & MRI) if they are all scheduled close to each other in date. If the subject wants to be paid separately for each procedure then you can submit individual payments.

3. Scheduling Study Visits

  • Schedule the participant for a physiology visit date and MRI visit date while you wait for them to complete their sleep report. MRI scanning slots at the BMC fill up quickly so it is important to try to reserve a time ASAP. You can always delete or change a reservation time without penalty if it is done 24-hours prior to the reserved time.

  • Reserve a parking permit for subject through the Automated Coupon Code portal.

    • Try to reserve parking in structure closest to location of their visit - Structure 2 for Factor & Structure 8 for BMC. Structure 9 does not have automated kiosks so do NOT reserve permits for that location.

    • Email the subject their reservation code and instructions on retrieving their permit from the automated kiosk.

    • Study visit and parking email templates/maps can be found HERE.

    • Email a copy of the Consent form to the subject ahead of the visit date to review prior to having them sign it on their visit date.

4. Physiology Visit

  • Physiology

    • Schedule Physiology Visit

      • Schedule a 3-hour block

      • Upon arrival, the subject should complete the following paperwork: Consent form, HIPAA authorization form for sleep study, W-9 & Subject payment information forms. Payment Forms can be found HERE. W-9 & subject payment information forms should be scanned and emailed to Stephanie Varela (SVarela@sonnet.ucla.edu) after the visit to process payment. Password protect the payment forms before sending the to Stephanie.

      • After the subject has completed the paperwork, complete the items below and record them on the Subject Information Sheet:

        • Weight and height using manual scale.

          • Once these two items are completed, use the OMRON to calculate BMI and Fat%.

        • Complete neck measurement

        • ABI using the Mesi 1-minute ABI device

        • Blood pressure reading (Make sure the subject has both feet planted on the ground).

        • Record any medications they have taken in the last 48 hours.

      • If this is a first visit; the Subject completes Everyday Survey, Baseline, Symptoms Timeline, Calgary (only OSA), and MoCA assessment,

        • In subsequent visits the subject should complete only the Everyday Survey and MoCA (different version than prior visit). Check with Paul to confirm this for for any pilot data collection or if you are unsure about a repeat subject.

      • After the subject leaves, be sure to wipe down and disinfect ALL equipment used during the visit. Valsalva and inspiratory loading tubes should be cut after each visit and disinfected. Be sure to check transmitters for power level and leave them charging if necessary.

      • After the visit, scan the subject info sheet and scored MoCA. Save both of these scans along with the Acqknowledge and fNIR files to the subject folder in the Raw Data folder. More detailed steps for this procedure can be found HERE

      • Subject receives $100 compensation for visit

5. MRI Visit

  • Schedule fMRI visit (some subjects may be excluded from the procedure)

    • Schedule a 2.25 hour block → 0.25 hr block prep + 2-hr scanning

      • Coordinate with the Radiology Team (Andres Saucedo, Ajin Joy) for their availability. Spectroscopy is usually completed in the second half of the scan so if a member of the Radiology team cannot be there for the non-spectroscopy portion make sure another MRI safety certified Macey lab member can be present or schedule for a BMC tech to be present during that portion. Techs are only available during business hours on weekdays.

      • Refer to the BMC MRI calendar for time availability in the scanner. Due to COVID, the BMC is requiring 30 minutes between scans but that may be subject to change. Techs email research groups with any policy/procedure changes regularly so be vigilant for emails from BMC Techs.

      • Scan times must be reserved directly through the ALBMC database. Instructions for reserving scan time can be found HERE

    • The subject should be asked to complete the BMC MRI screening form before the scan. Be sure that this is completed well ahead of their scan date to allow time to get any implants cleared if necessary. If they are unable to email a completed form back to you, perform the screen over the phone with them and have them sign the form, first thing when they arrive for their scan.

    • Subjects should be told that they need to arrive to their scan appointment 15-minutes prior to the start time to allow them time to change into gown and to perform metal screening.

      • Before the subject arrives, enter the subject changing room and place gown top, pants, and one of the BMC masks out for them on the table. The Subject has the option to wear the mask in the scanner (only the BMC masks can be worn in the scanner!). The subject and research staff are required to have a mask on at ALL times in the building with the exception of the subject choosing not to have one on while in the scanner. They must place a mask on after they are pulled out of the scanner.

    • Download scan files from BMC servers immediately after the scan. You will need to connect to BMC via VPN to access the files. Instructions to connect to via VPN are found HERE. If you are having issues contact James Widanta (jwidanta@ucla.edu) at the BMC.

      • If this step cannot be completed right away, do this at the first opportunity possible to prevent any lost files. BMC Techs will routinely delete scan files to free up server space.

    • Convert DICOM files

    • Subject receives $150 compensation for visit

    • More detailed steps for this procedure can be found HERE

    • See Administrative section at the bottom for BMC requirements

6. Data Management

  • Subject folders in Raw Data (W drive) should contain the following items:

    • Copy of sleep report

    • Physiology files (Aqknowledge, fNIRs, scans of subject data sheet and scored MoCA)

    • MRI files (some subjects are excluded from this so there will not be any scan files)

    • After completing any procedure, check files to ensure data quality.

      • If there is an issue with physiology or MRI data, check with Paul and reschedule the subject if necessary for that procedure if they are willing to come in again. Subject still receives compensation for both sessions.

 

 

Administrative

Brain Mapping Center Approvals http://www.bmap.ucla.edu/services/scheduling/add_update_irb_document/