Accession Number:

ADA574630

Title:

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Descriptive Note:

Annual rept. 1 Sep 2010-31 Aug 2011

Corporate Author:

NORTHERN CALIFORNIA INST FOR RESEARCH AND EDUCATION SAN FRANCISCO

Personal Author(s):

Report Date:

2012-09-01

Pagination or Media Count:

100.0

Abstract:

During Year 3, revisions were made to the protocol, informed consent, and HIPAA documents to allow for additional data collection during the hospital portion of the study via actigraphy. Recruitment materials were also revised in order to target a non-smoking population. This greatly reduced the amount of participants ruled out during the phone screening process, improving phone screening success. Safety reports continue to be sent to Actelion on a monthly basis. Both blinded and unblinded monitoring visits of study procedures and facilities are ongoing. Throughout Year 3, many new study team members were hired and trained Study Coordinator, Recruiter, Research Assistant, and Lab Manager. The study team also expanded to include additional informed consent administrators, clinical interviewers, as well as sleep technicians and neuropsychological assessment administrators in order to reach the new quarterly enrollment goal of 39 participants. Enrollment is expected to increase throughout Year 4 due to the actions taken above.

Subject Categories:

  • Psychology
  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE