A Message from the Chief Medical Officer | | |
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I want to thank all the sites for your effort and dedication bringing the SynAIRgy study to life for patients across the US. The study is enrolling well and on schedule.
As covered at the investigator meeting, the study is designed to enroll a representative number of patients in each of three OSA severity groups: mild, moderate and severe.
The very similar sister study to SynAIRgy, called LunAIRo, started enrolling a few months ago, and based on enrollment in LunAIRo Apnimed has been able to make a number of improvements to the SynAIRgy study that will come into effect in Version 4.0.
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Version 4.0 allows for enrollment of an equal proportion of patients across the three severity strata, and sets this proportion more widely, at ~20-40% each, which should speed enrollment. Because more patients with severe OSA will be enrolled, a maximum AHI4 of 45 has been set.
Version 4.0 of the SynAIRgy study also expands enrollment to include an exploratory cohort of up to 100 OSA patients taking GLP-1 agonists specifically for weight loss. These patients were previously excluded because weight loss might change OSA severity over the course of the study, but this issue has been addressed by plans to analyze these patients separately from the main study cohort.
All protocol activities are identical for this exploratory cohort but, importantly, when randomizing participants, it will be important to indicate in the randomization system whether participants are in the regular cohort, or in this new exploratory cohort.
Syneos will notify you when protocol 4.0 goes into effect.
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Invoicing and Payment Reminders | |
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We appreciate your contributions to this study and therefore, endeavor to provide site payments in a timely manner. In order to do so, we have provided a few reminders below, that will help expedite your payments.
- Please ensure that you are utilizing the Greenphire Portal to submit requests for patient reimbursement. Information regarding the submission process can be found in the SIV slides.
- It is not necessary to invoice for screen failures. We receive this information when the screen fail is entered in EDC. Only then, can the visit be processed for payment.
- If you have entered a subject visit as a screening visit, but it should have been a screen fail, please inactivate the pages that were completed for the screening visit and re-enter the information as a screen fail.
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All invoices and payment related queries must be forwarded to the following as instructed:
Attn. Investigator Payment Department
Syneos Health, LLC
1030 Sync Street
Morrisville, NC 27560 USA
Re: Project Code 7041290
Email: [email protected]
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Each invoice must contain:
- Sponsor’s name,
- Protocol number,
- Project code,
- Principal Investigator’s name,
- A summary of the reimbursement to be made in compliance with the Financial Arrangements Worksheet, and
- Site number.
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- The Core Team Role and System Access Form will trigger several activation steps. If you have not completed it yet, return the form as soon as possible. Contact Lisa Schlosz at [email protected] or your CRA if you have not received the access form.
- Complete the test ECG if you have your machine.
- The test PSG can take some time. Please plan ahead with the sleep lab to have this scheduled and submitted as early as possible. Once the test PSG is approved, there is one final Redcap training needed.
- For EDC access, search your email for this address [email protected], if you are having trouble finding the EDC access request.
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We are happy to announce that edit checks for APC-APN-305 have successfully moved into production.
Note: Minimal data will be captured in RAVE until the participant is determined to be eligible for Randomization at Visit 3. Site Visit, Informed Consent, Demographics and Subject Eligibility are required for completion in RAVE until Randomization occurs.
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If a Subject decides to withdraw from IP, but would like to remain in the study, please "Early Terminate" them in Suvoda. Complete and End of Treatment page in RAVE.
DO NOT complete "End of Study."
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Updates to the Lunexis Platform: Once a subject completes the MADRS and PROMIS Questionnaires, an automatic populated screen will appear, prior to completing the next assessment that will display the PROMIS F Score and Question 9 “Zest For Life” Score (on the MADRS scale).
This Change Control was implemented to help reduce both Site/Subject wait times.
Optional Clinical Ink Training: Clinical Ink will hold optional Web Trainings to review both their Lunexis and BrainBaseline Platforms.
There will also be a Q&A session at the end of each training for any additional follow-up.
The recently implemented Scoring Report will be reviewed, along with instructions on creating DCFs within the Clinical Ink System.
APC-APN-305 Optional Web Trainings are scheduled for January 24th and 26th 2024; Web Trainings are optional and not required.
US-Spanish/Eng-French Canadian Translations: Expected to Go-LIVE in JAN2024; Your sites CRA or Syneos Study Team will notify all sites, when LIVE.
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ECG Exclusion Criteria
ECG abnormality indicative of clinically significant cardiac disease is exclusionary (Exclusion #25), to be consistent with labeled warnings for atomoxetine.
ECG findings that are exclusionary include, but are not limited to, those listed below (investigators may also determine that ECG findings not specifically listed should exclude an individual).
The ECG reading central report will indicate exclusion if any of the below parameters are identified on an ECG.
Exceptions to these exclusionary ECG criteria are not allowed in the study.
If medical history or prior ECG indicates one or more of these ECG exclusions, the patient typically should not be screened for enrollment.
ECG Exclusion Criteria:
- HR > 90 bpm
- PR > 240 ms
- QTcF:
(a) If QRS duration < 120 ms,
exclude for QTcF > 480 ms
(b) If QRS duration > 120 ms,
exclude for QTcF > 510 ms
- Supraventricular Tachycardia
- Nonsustained Ventricular Tachycardia
- 2:1 AV Block
- Mobitz II 2nd Degree AV Block
- Complete Heart Block
- ST elevation
- Brugada Syndrome
- Abnormal U waves
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Please note that if a subject screen fails, only Site Visit, Demographics, and Subject Eligibility pages are required for completion in RAVE. | | |
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CYP2D6 testing Important Reminder
The CYP2D6 test is useful for post-hoc analysis of aggregate group data only, it is not a test used for determining eligibility or monitoring safety or efficacy of an individual patient during the trial.
Sites do not need to wait for CYP2D6 results to proceed with screening or randomization.
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Reminder: Please upload PSGs within 24 hours after collection to allow for at least 5 business days for Sleep Strategies to return the results to you.
They will strive to get baseline PSGs returned to you within 2 to 3 business days.
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Please note that the SAE Report Form, SAE Form Completion Guidelines, and SAE fax/email cover sheet have been updated by removing AESI.
AESIs only need to be documented in source and RAVE.
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Instructions for sites on how to order additional ClinCards via the Greenphire portal.
Log into https://support.greenphire.com/
From there, sites will need to fill out the required fields to complete the order. Please note that all required fields are not listed in the screenshot:
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Fast Start Enrollment Incentive! | |
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Just a reminder to recently activated sites: The "Fast Start Enrollment Incentive" is available to sites that randomize up to two patients within the first 45 calendar days of activation.
"Fast Start" Math:
- Randomize 1 patient = additional $1,000 total
- Randomize 2 patients = additional $2,000 total
- Randomize 15 patients = WOW! and...additional $2,000 total (that's the max!)
Be sure to take advantage of this program.
How? Your patient database, your recruitment efforts, Apnimed's recruitment tools and online outreach vendors (Galen and SubjectWell). You have many resources at your disposal.
The following sites recently earned the maximum Fast Start Enrollment Incentive of $1,000/subject for the first two subjects!
- Centennial Medical Group
- Abington Neurological Associate.
Please contact your monitor if you have questions about the program.
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Apnimed has an in-house patient recruitment team dedicated to helping your site succeed with recruitment. Below, you will find a list of tools and resources that the team is working on for you.
- Study-Specific Website (SynAIRgyStudy.com)
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Site Specific Recruitment Plans to help get your site up and running with recruitment as quickly as possible.
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Online pre-screener to help pre-qualify referrals
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Free patient referrals via recruitment vendors, Galen and SubjectWell
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Social Media: Facebook & Google Ads
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Site Specific Materials including phone pre-screener script, chart review checklist, doctor to doctor referral letter, doctor to doctor study overview PowerPoint presentation
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Patient Facing Materials including posters, brochures, postcards, doctor to patient letter, e-mail message template, medical records messaging, radio script, newspaper ads, Spanish translations of patient facing materials
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Community-Based Outreach attending local health fairs and community events in select site locations
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Site Specific Recruitment Plans | |
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As communicated during your site initiation visit (SIV), as well as at the investigator meeting, the patient recruitment team will contact every site to schedule your 60-minute baseline site specific recruitment plan meeting.
During that time, we will discuss enrollment goals, and share ways that the recruitment team can assist, including getting your site set up with our online recruitment partners, Galen and SubjectWell, which provide free, pre-qualified referrals to your site.
It is important that your team respond to the Apnimed patient recruitment team's request to schedule your initial 60-minute site-specific recruitment plan meeting and monthly recruitment check-in Zoom calls, which typically take 30 minutes or less.
These meetings are designed to give your site customized, hands-on recruitment support to help reach your goals and maximize successful enrollment.
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Centralized Recruitment Campaigns | |
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The Apnimed patient recruitment team is providing free pre-qualified referrals to sites through our online vendors, SubjectWell and Galen.
Please encourage your staff to do the following:
- Respond to recruitment meeting requests,
- Follow up with referrals in the portals within 1-2 business days, and
- Continue to follow up with referrals after your team leaves an initial message.
Please note that recruitment campaigns may be paused, if referrals remain unanswered.
Click the link below to review useful tips for managing your site's referrals from Galen and SubjectWell.
https://tinyurl.com/GalenTips
If you have any challenges with managing your referrals, want to start your own recruitment campaigns or wish to pause your campaigns, please reach out to the recruitment team at [email protected] and copy your monitor.
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As we completed our first two months of enrollment, we are happy to share that, as of January 16th, 4sites have already randomized 8 patients!
Kudos to Dr. Geller's site, Centennial Medical Group, for screening the first patient on November 29th, AND to Dr. Khoury's site, Abington Neurological Associate for randomizing the first patient on December 20th!
Below is the complete site list of sites with randomized patients.
Thanks to your efforts, we are off to a very strong start!
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Enrollment As of January 16, 2024 | |
SynAIRgy Sites Across North America | |
With 65 sites scheduled to participate, the SynAIRgy study features a diverse site population spread across the country. | |
Thank you for your dedication to the SynAIRgy study! | |
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Please notify us if you wish to add team members to the distribution list to receive future study newsletters.
If you have any questions about recruitment, please reach out to your study monitor, as well as Apnimed’s Patient Recruitment team at [email protected].
Thanks for your continued participation!
~ The SynAIRgy Study Team
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