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
You should refer to the Subject and Data Tracking Sheet to assign the subject a 4 digit code.
Review the Population Survey on Qualtrics once the subject has completed the survey to ensure continued eligibility.
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.
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.
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.
Reserve a parking permit for subject
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.
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%.
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, MoCA assessment, Baseline, Symptoms Timeline, Calgary (only OSA).
In subsequent visits the subject should complete only the Everyday Survey and MoCA (different version). Check with Paul to confirm this for specific subjects.
Save Acqknowledge files and fNIR files to subject folder in the subject Raw Data folder. More detailed steps for this procedure can be found /wiki/spaces/OSAProject/pages/865140741
Subject receives $100 compensation for visit
Schedule fMRI visit (subject may be excluded)
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.
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
/wiki/spaces/OSAProject/pages/45318153 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.
Subject receives $150 compensation for visit
More detailed steps for this procedure can be found /wiki/spaces/OSAProject/pages/11075618
See Administrative section at the bottom for BMC requirements
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.
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Brain Mapping Center Approvals http://www.bmap.ucla.edu/services/scheduling/add_update_irb_document/