7A-SUPP-005 — Termination Reports: Confirmed-Access Cohort
This file was generated on September 18, 2013 following conclusion of data collection under Protocol 7A (EC-004). It contains recall termination assessments for participants with confirmed environmental access events (EEC score 4.0 or above across two or more sessions). Five participants met the threshold at study conclusion. All five are classified as Archive Category 7.
Archive Category 7 — Active status. These records are not subject to standard retention expiration. Category 7 records are maintained as active and are subject to scheduled recall observation at intervals determined by the Archive Committee. Records in this file were not transferred to Dorsal Health Holdings LLC in November 2014 per agreement between the clinical coordinator and the research affiliate.
Participant Termination Report PTX-007
Participant ID PTX-007 Study entry 2008-11-04
Total sessions 18 EEC category Confirmed access — threshold met session 12
Termination date 2013-06-14 Archive status Transferred
Termination type Study conclusion — protocol end date

PTX-007 completed 18 sessions across the full study period. Confirmed environmental access was established at session 12 with consistent EEC scoring above threshold on items 01 through 08 and item 11. Cross-participant consistency with PTX-014 and PTX-031 was documented in the 7A-SUPP-002 cross-reference table.

PTX-007 was the first participant to provide an unprompted corridor description consistent across cohort. Session 12 technician note: “Patient described a bending hallway and a blue door to the left. Did not use study language. Consistent with P-014 S09.”

Follow-up interview conducted June 2013. Participant reported ongoing access-consistent recall without in-lab conditions. This is noted in the Archive Committee record. Category 7 classification applied at study conclusion.

Participant Termination Report PTX-011
Participant ID PTX-011 Study entry 2009-02-09
Total sessions 14 EEC category Confirmed access — threshold met session 09
Termination date 2013-06-14 Archive status Transferred
Termination type Study conclusion — protocol end date

PTX-011 completed 14 sessions. EEC threshold met at session 09 with confirmed item 11 scoring (room designation: 413, unprompted). Notable for item 10 cross-reference: PTX-011 was the first participant to describe the vending machine feature at session 11, predating PTX-018’s session 22 note by 14 months.

Session 11 technician note: “Patient described a machine built into the right wall of the hallway that accepts room keys. Did not elaborate on what it dispenses. Did not appear distressed by this. Noted for cross-reference.”

Follow-up interview conducted June 2013. Participant reported no recurring access. Category 7 classification applied per protocol. Record closed at study conclusion.

Participant Termination Report PTX-014
Participant ID PTX-014 Study entry 2009-01-19
Total sessions 22 EEC category Confirmed access — threshold met session 08
Termination date 2013-07-01 Archive status Transferred
Termination type Study conclusion — protocol end date

PTX-014 completed 22 sessions, the maximum in the cohort. EEC threshold met at session 08. Ellison correspondence note March 2012 flagged PTX-014 session 22 as the first session in which a participant described “going through” the blue door. This language was not used by any prior participant. Session 22 produced the first explicit description of the space beyond the door.

Session 22 technician note (L. Ortiz): “Patient described opening the blue door. Described a large room, high ceiling, a hallway continuing from the far end. Bending left. The light was described as coming from everywhere. Patient calm throughout. I did not prompt for elaboration. I am noting this separately.”

Follow-up interview June 2013. Participant reported no ongoing access. Category 7 applied. Record transferred at study conclusion. Cross-reference: 7A-SUPP-002 (environmental consistency), 7A-SUPP-004 (room 413 notation).

Participant Termination Report PTX-018
Participant ID PTX-018 Study entry 2009-03-14
Total sessions 22 EEC category Confirmed access — threshold met session 07
Termination date 2013-01-22 Archive status Concluded
Termination type Participant-initiated withdrawal — session 22

PTX-018 completed 22 sessions before requesting discontinuation at the conclusion of session 22. EEC threshold met at session 07. Highest overall EEC consistency scores in the cohort: 5/5 across all items by session 15. Session 20 produced the first explicit unprompted naming of room designation 413.

Session 22 patient note (L. Ortiz): “Patient requested discontinuation. Reports dreaming about this office. Patient calm, oriented, no apparent distress. Withdrawal processed per EC3 Section 4. Referred to Dr. Ellison for follow-up notation.”

Dr. Ellison notation, January 23, 2013: “PTX-018 requested discontinuation citing recurrent recall of the clinic during waking hours. Patient denied distress. I believe patient understood more of the study than the consent language covers. I am noting this for the archive record and for the EC-004 review in March.”

Follow-up interview declined by participant. Category 7 classification applied per EC-004, Section 8.3. Record status: Concluded. Note: participant withdrew before study end date; category 7 status remains active per Archive Committee determination, January 2013.

Participant Termination Report PTX-031
Participant ID PTX-031 Study entry 2010-08-30
Total sessions 16 EEC category Confirmed access — threshold met session 11
Termination date 2013-06-14 Archive status Active
Termination type Study conclusion — protocol end date

PTX-031 completed 16 sessions. EEC threshold met at session 11. Cross-participant consistency with PTX-007 and PTX-018 documented in 7A-SUPP-002. PTX-031 is notable as the only confirmed-access participant who, during the session 16 post-interview, described a second door at the end of a secondary hallway. This feature was not present in any prior session record for any participant.

Session 16 technician note (L. Ortiz): “Patient described a branch hallway off the main corridor, approximately 15 meters, ending in a grey door with a printed label. Patient could not read the label. Patient described the label as a standard room sign. Patient did not appear concerned by this. I filed this note separately. I am going to ask Dr. Ellison about this in the morning.”

Follow-up interview June 2013. Participant reported ongoing recall of the secondary hallway during waking periods, initiated approximately three weeks before study conclusion. This is the only instance of waking-state recall onset prior to study conclusion in the confirmed-access cohort.

Archive status: Active. Record not closed at study conclusion per Archive Committee notation June 2013. Category 7 applied. PTX-031 is the only confirmed-access participant with Active (not Transferred or Concluded) status at the time of this report. Reason for Active status: ongoing waking-state recall consistent with continued access, documented post-conclusion. Standard recall communication issued: PLEASE WAIT TO BE RECALLED.

Archive Committee notation — September 18, 2013 (M. Ellison)
This file contains the complete confirmed-access cohort as of study conclusion. All five participants are classified Category 7. Four records are closed (Transferred or Concluded). PTX-031 is Active.

I want to note for the record that PTX-031’s session 16 description of the secondary hallway and the grey door with the printed label is consistent with what I personally observed during access event 4 on April 7, 2013. See 7A-SUPP-010 for that account. PTX-031 described it in session 16, which was recorded in November 2012. I did not access the secondary hallway until April 2013.

PTX-031 described something I had not yet seen. I do not know what to do with that.

This file is retained in the Somnatek archive and was not transferred to Dorsal. The Archive Committee is aware that active Category 7 records will remain active regardless of institutional transfer. The recall system does not close.