Consultant, Clinical Trial Operations

Advised Dr. Thomas Neylan’s research team on deployment of NIMH’s 1-million-dollar Cognitive Behavioral Treatment of Insomnia in Post-Traumatic Stress Disorder Study: a randomized, 2‑arm controlled trial examining whether CBTi improves sleep in PTSD patients.

• Developed strategy to launch a complex neurocognitive test battery for the clinical trial.

• Proposed quality control procedures and created training materials to insure the ongoing integrity of the research data.

Prilipko O, Huynh N, Tantrakul V, Kushida C, Leary E, Nichols D, Guilleminault C. Changes in Cerebral Activation on Working Memory Task in Obstructive Sleep Apnea patients after CPAP or sham CPAP treatment. Sleep, June 2009, Vol. 32 (Abstract suppl.), p.A225; #0691.

Huynh N, Prilipko O, Tantrakul V, Nichols D, Leary E, Kushida C, Guilleminault C. fMRI Study of CPAP Treatment on Verbal Memory Encoding in Obstructive Sleep Apnea Patients in Comparison to Healthy Controls. Sleep, June 2009, Vol. 32 (Abstract suppl.), p.A224; #0686.

Senior Manager of Clinical Research

Responsibilities included leading scientific and technical initiatives, writing grants/proposals, performing statistical analysis and power calculations for grant applications/publications, designing research studies/clinical trials, developing budgets, negotiating contracts, and actively building successful collaborations with internal and third-party organizations.

• Project Director for the Stanford Technology Analytics and Genomics in Sleep (STAGES) study: a prospective study that will sleep related data on 30,000 sleep clinic patients (age 13 and up) including genetic and phenotypic data.

  • Managed the study at the strategic level to ensure that the project progresses on time and on budget. Chair the Operations Committee, coordinated the development of the data management portal, provided high-level oversight for data collection, and managed the databases and servers for and secure storage and sharing.

• Project Director for the Alliance Sleep Questionnaire (ASQ): an online questionnaire that uses complex, branching logic to identify potential sleep disorders.

  • Partnered with stakeholders from 5 institutions to develop the ASQ’s content, conducted the pilot study, managed deployment, and integrated the new tool into the core workflow at Stanford’s Sleep Clinic. Responsible for the ongoing management of the ASQ (monitoring data acquisition and integrity, assessing data quality, developing scoring algorithms, and performing data analysis). To date, the ASQ has been completed by over 20,000 people, is critical for >10 research studies (including STAGES and Google baseline pilot), and has become standard of care at the Stanford Sleep Medicine Center.

• Helped department secure >40 million dollars in funding by directing the submission of 15 grant applications (9 funded).

  • Grants included an 18-million-dollar family foundation grant to build a prospective cohort of 30k sleep clinic patients and a 7.85 million dollar NIH P01 grant to research the genetic, neurobiological, and immunological basis of type 1 narcolepsy.

• Database Architect/Administrator for the Stanford Sleep Cohort and Narcolepsy Cohort.

  • Created system to link clinical, research, and sleep study data on >40,000 individuals including biological data on >5,000 narcolepsy cases and >15,000 controls. Optimized data security and operational effectiveness by providing technical expertise and developing both the schema and data dictionaries.

• Implemented and managed Stanford’s Multi-site PSG Triple Re-Score Project.

  • Authored manual of operations for the Stanford Site, developed a partnership with Philips Respironics to streamline data-export of >500 studies, hired/managed scoring techs, produced final dataset, and provided regular updates to the project’s steering committee.

• Program and Technical Director of Stanford’s Accredited Sleep Technologist Education Program.

  • Developed A-STEP’s course curriculum (including speakers and materials), managed all administrative requirements (enrollment and record keeping), and presented lectures on various topics ranging from sleep scoring to patient hook‑ups.

• Provided operational oversight for 10 clinical studies with sample sizes ranging from 40 to over 8,000.

• Composed/managed >40 department active IRB protocols (involved updates/renewals, adherence to regulations, and coordination of inter‑institutional agreements with >25 collaborators).

Dement WC, Leary EB. Sleep disorders: a widely ignored pandemic. FOCUS: Journal for Respiratory Care & Sleep Medicine, Jan 2009:28.

Katikireddy C, Nguyen P, Won C, Cardell C, Nichols D, Leary E, McConnell M, Holmes TH, Kushida CA, Yang P. Multimodality Cardiovascular Imaging Detects Improvement of Subclinical Microvascular Dysfunction with Continuous Positive Airway Pressure Therapy in Obstructive Sleep Apnea Patients: A Prospective, Randomized, Double-blinded Study. Circulation, 2007, 116:II, 846, Abstract 3722.

Kushida CA, Nichols DA, Quan SF, Goodwin JL, White DJ, Walsh JK, Schweitzer PK, Guilleminault C, Simon RD, Leary EB, Hyde PR, Holmes TH, Bloch DA, Green S, McEvoy LK, Gevins A, Dement WC. The Apnea Positive Pressure Long-term Efficacy Study (APPLES): rationale, design, methods, and procedures. J Clin Sleep Med., 2006 Jul 15; 2(3): 288-300. PMID:17561541.

National Coordinator / Central Scoring System Manager

Responsible for overall operations on NHLBI’s 14.1-million-dollar Apnea Positive Pressure Long-term Efficacy Study (APPLES): a 6-month, randomized, double-blind, 2‑arm, sham-controlled, multi-center trial to assess the long-term effectiveness of nasal continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) with >1,516 enrolled subjects.

• Ensured program excellence across 5 university, hospital, and private practice sites.

  • Performed annual site audits, organized and chaired monthly quality assurance meetings, provided operations advice, and made recommendations to promote staffing diversity. Monitored monthly subject enrollment and retention goals for all clinical centers.

• Created procedures and tools to foster standardization and data integrity.

  • Collaboratively produced a detailed manual of operations and >100 case report forms to help ensure adherence to protocols and the collection of consistent, high-quality data.

• Assisted in developing a robust, online data entry and management system that effectively collected and managed >8 million data points.

• Managed Central Scoring System for APPLES and the APPLES fMRI Study.

  • Designed and implemented a database to track >20,000 sleep studies. Developed and implemented the program’s quality control and quality assurance procedures, including a detailed instruction manual. Hired and managed team of up to 15 remote technicians.

• Supervised data collection at Stanford’s Clinical Center.

  • Ensured high-level care was provided to the >400 subjects enrolled at Stanford. Recruited, trained, and supervised a diverse team of 12-16 staff members.

• Assisted Dr. Clete Kushida in developing/implementing subsequent clinical trials, including APPLES fMRI, APPLE CORS, and TOPS.

Project Manager / Stanford Liaison

Managed projects for Stanford’s Dr. William C. Dement to raise public awareness of the importance of sleep.

• Developed educational materials for helping long-haul truck drivers improve their sleep quality and safety practices.

• Worked with third party organizations to incorporate the importance of sleep into college and high school curricula.

• Developed research protocol for testing the efficacy of SleepQuest’s treatment pathway. Results published and presented at 2006 SLEEP conference.

• Worked with Stanford physicians to develop an annual sleep education course for a family practice clerkship (including tests for assessing efficacy).

• Improved CPAP adherence for over 100 patients through one-on-one appointments.

Trotter K, Leary E, Claman D, Evaluation of EPMS Optiflex Compared to Esophageal Pressure (Pes). Sleep, June 1999, Vol. 22 (Abstract suppl.), pA47.

Leary E, The Effects of Smoking Cessation on Sleep. Sleep, June 1998, Vol. 21, (Abstract suppl.), p.A261.

Trotter K, Wong R, Leary E, Claman D. Non-Invasive Assessment of UARS: EPMS Optiflex Diaphragmatic EMG (dEMG), and Esophageal Pressure (Pes). Sleep, June 1998, Vol. 21 (Abstract suppl.), p.A185.

Contractor

Key contributor on research team examining the effects of Post-Traumatic Stress Disorder on sleep.

• Analyzed and scored sleep studies per project-specific metrics.

• Performed patient hook-ups and calibrated data collection software.

Registered Polysomnographic Technologist

Conducted MSLT, MWT, and overnight sleep studies (PSGs) including full apnea hook-ups, PAP/BiLevel titrations, TCCO2, and PES calibration and monitoring.

• Scored >150 sleep studies for sleep stages, breathing events, arousals, and leg movements.

• Improved patient health by developing/implanting a proactive PAP adherence program.