Clinical Trials/Outcomes
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Pregnancy Study
Insomnia-Elderly Study
BestSleep (Harvard/Yale)
INCOSACT
HARVEST
A Planning Study: Designing a Sleep
Apnea Intervention in Pregnancy
• Funding mechanismR34 NHLBI
• $450,000 over 3 years
• Performance sites:
– Case Western Reserve University (J Louis)
– University of Michigan (L O’Brien)
– BWH (Reading Center, S Redline)
• Collaborators
Ghada Bourjeily MD-Brown University
Ellen Lockhart MD- Washington University
Michelle Okun PhD-Univ Pittsburgh
Grace Pien, MD, MSCE-Penn
• Additional Participants Contributing to study
design:
• Steve Duntley, MD
Wash U
• Bilgay Izci Balserak, PhD Penn
• Aaron Laposky, PhD
NIH
• Ulysses Magalang
OSU
• Katie Sharkey, MD, PhD Brown
Specific Aims
• Specific Aim 1: To Estimate the recruitment yield and
acceptability of a 2 stage screening process using
questionnaires and portable polysomnography to detect OSA
in pregnant women
• Specific Aim 2:
– a.) To estimate the adherence to PAP therapy
– b.) To identify the barriers to adherence
• Specific Aim 3: Estimate the change in mean blood pressure
associated with 6 months of PAP therapy
• Specific Aim 4: Identify the feasibility of collecting and
processing fasting blood specimens using two CTSA research
units
Study Design Overview
Baseline visit
2nd trimester
visits
3rd trimester
visit
Morphometric
Measurements
Questionnaire
Questionnaires
Morphometric
Measurements
Morphometric
Measurements
Venipuncture
BP measure
BP measure
PSGN=400*
Venipuncture
Venipuncture
BP measure
AHI≥5
N=80
PAP
N=40
*Will over recruit obese women with comorbid conditions
Assumes a 20% screen positive rate
Assumes a 50% acceptance of CPAP treatment
CBTi vs Pharmacotherapy for
Insomnia in the Elderly
• K Stone (PI, CPMC)
– ARRA Planning Grant
• Tested sleep clinic vs community recruitment
• Refined CBTi and study procedures (C Morin and others)
• Ultimate outcomes-falls and fractures (Sleep, function)
– Participants in larger study identified via SRN
– Large budget- NIA indicated it would not accept
• Revising protocol (CER)
– Reduce budget/streamline
– June submission if NIA accepts
CVD Planning Studies
• HeartBEAT
– ARRA funded Phase 2
– CWRU, BWH, BMC, JHU Over one year, randomized 318 pts with
moderate OSA/CVD to 3 month intervention:
• optimized medical care
• supplemental oxygen
• CPAP
– Outcome: 24 BP (biomarkers, endothelial function, function)
– Established strength of cardiology clinic recruitment
– Phase 3 planning
CVD Planning Studies
• BestSleep
– BestAIR (Best Apnea Interventions in Research)
– SleepTight
– Coordinated, NIH supported planning studies
• Harvard (Mittleman, Redline), Yale (Yaggi) and Indiana
University (Bravada)
– Key feasibility issues (adherence, retention,
recruitment)
INternational COllaboration of Sleep Apnea
Cardiovascular Trials (INCOSACT)
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Grass Roots: McEvoy (SAVE; AU) and Redline (HeartBEAT; US) began a dialogue
with NIH
– NIH workshop coincidentally identified Sept 2010
– Proposed satellite conference in Bethesda, MD
– Secured donations from Philips-Respironics and ResMed Foundation
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September Bethesda Meeting
– McEvoy and Redline agreed to be interim Co-Chairs of Steering Commitee
– Identified international representatives: Barbe, Stradling, Lorenzi, Ip, Bradley
– Arranged for AASM to provide secretarial functions
– Identified web resources for leveraging via Australian Clinical Trials
INternational COllaboration of Sleep Apnea
Cardiovascular Trials (INCOSACT)
• Collaboration of investigators interested in conducting
randomized controlled clinical trials of Sleep Apnea treatment
interventions that aim to adjudicate cardiovascular disease
(CVD) event information.
• Intended to promote the collection of evidence needed to
inform the global community on the role of sleep apnea
interventions to reduce CVD morbidity and mortality.
INternational COllaboration of Sleep Apnea
Cardiovascular Trials (INCOSACT)
• Specific aims are to promote:
• Sharing of relevant resources to promote high quality clinical trial data
collection and future harmonization and sharing of data-e.g., questionnaires;
procedure manuals etc.
• Sharing of expertise in strategies to improve the design of clinical trials, such
as approaches for enhancing treatment adherence, addressing equipoise,
selecting appropriate control conditions
• Planning for later meta-analyses
• Publicization of clinical trials
• Dissemination of information on methods and outcomes to the general
scientific community
INCOSACT Membership and Focus
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Open to all investigators undertaking Phase II as well as Phase III trials of sleep
apnea interventions for the reduction of cardiovascular disease.
– Potential Expansion Later
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Governance is through a Steering Committee with rotating membership every 2 to
3 years and with global representation.
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Proposed Subcommittees
– Information Sharing Subcommittee: Content Advisors on materials for data
sharing (questionnaires, manuals, publications, study information
– Analysis Subcommittee: To plan approaches for meta-analyses
– Operations- To provide input on emerging relevant clinical trials and
interventions and dissemination approaches