IRB Amendment Filings — WU-CBN-2007-044

Protocol: WU-CBN-2007-044 — Longitudinal Sleep Recall Study (Protocol 7A)
IRB Reference: Wexler University Institutional Review Board
Original approval: November 2007
Final status: Concluded — co-investigator withdrawal approved January 2013

Amendment Log

Amendment Date Filed Description Status
EC-001 March 2009 Extension of enrollment window by six months. Increase in maximum session count per participant from 18 to 24. Approved
EC-002 January 2010 Addition of supplemental recall facilitation sessions. Introduction of audio environmental cue protocol for eligible participants. IRB filing describes method as "supplemental environmental recall facilitation." Approved
EC-003 September 2011 Revision to recall inventory instrument. Addition of spatial orientation and directional recall items. Removal of direct verbal prompting from technician protocol for sessions 8 and beyond. Approved
EC-004 March 2012 Introduction of extended observation windows for participants demonstrating elevated environmental recall consistency scores (EEC ≥ 4.0 across two or more sessions). Addition of cross-participant comparative review as a secondary data collection activity. Note from IRB: observational categories introduced in EC-004 were not present in the original IRB submission and are not covered by the original approved scope. Somnatek Sleep Health Center was advised to ensure continued data collection under these categories was covered by an appropriate institutional review. No follow-up filing was received. Approved with conditions

Co-Investigator Withdrawal

Dr. Edwin Vale filed a withdrawal of co-investigator status on November 12, 2012. Withdrawal was approved by the IRB on January 7, 2013. Study data and records were transferred to Somnatek Sleep Health Center as sole custodian effective January 7, 2013. The department does not hold Protocol 7A study data.

The IRB noted at the time of withdrawal approval that the expanded observational scope introduced under EC-004 was not covered by the original approved protocol. This notation was provided to Somnatek Sleep Health Center and is part of the withdrawal record. No further communication was received from Somnatek or from Dorsal Health Holdings LLC regarding IRB compliance for the EC-004 categories.