Comparative Outcomes Management With Electronic Data Technology (COMET) Study (COMET)
STAGE I of the COMET study is to develop an Electronic Network Informatics Infrastructure that will prospectively enable access to and the sharing of clinical and research data.
STAGE II: This is a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study will be incorporated in Part 3 of the STAGE I study.
STAGE III of the COMET study is completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We will also explore expanding ontologies, and the use of federated database methodology.
Sleep Apnea, Obstructive
Device: Positive Airway Pressure
Device: Oral Appliance
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RO1: Comparative Outcomes Management With Electronic Data Technology (COMET) Study|
- Nocturnal mean arterial blood pressure [ Time Frame: 2 months ]Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment
- Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: 2-6 months ]Mean arterial blood pressure (systolic and diastolic), average real variability, and standard deviation during sleep and wake periods as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months and 6 months of treatment
- Vascular Ultrasound (VU) [ Time Frame: 2-6 months ]Compare readings from flow-mediated vasodilatation (FMD) of the brachial artery.
- Cardiovascular MRI (cMRI) [ Time Frame: 2-6 months ]Stanford Site Only: To explore cardiovascular functions by evaluating the changes of myocardial perfusion reserve (MPR), left ventricular ejection fraction (LVEF), and left ventricular mass (LVM).
- Cardiovascular / Inflammatory Biomarkers [ Time Frame: 2-6 months ]To explore C-reactive protein (CRP), tumor necrosis factor-alpha (TNFa), and interleukin-6 (IL-6).
- Psychomotor Vigilance Task (PVT) [ Time Frame: 2-6 months ]To evaluate the variance of number of lapses and mean reciprocal reaction time.
- Epworth Sleepiness Scale (ESS) [ Time Frame: 2-6 months ]To compare the total score.
- Profile of Mood States (POMS) [ Time Frame: 2-6 months ]To evaluate the total mood disturbance score and score on the fatigue-inertia subscale.
- Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) [ Time Frame: 2-6 months ]To evaluate the overall score.
- Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: 2-6 months ]To evaluate the overall SAQLI score.
- Short Form-36 (SF-36) [ Time Frame: 2-6 months ]To evaluate the role-physical scale and vitality scale scores.
- Quality of Well-Being Self-Administered Scale (QWB-SA) [ Time Frame: 2-6 months ]To evaluate overall QWB-SA score
- Cost-effectiveness [ Time Frame: 2-6 months ]Quality-adjusted life years and units of utilization throughout the study
- Treatment Efficacy [ Time Frame: 2-6 months ]Improvement of apnea-hypopnea index and oxygen desaturation index at treatment polysomnography
|Study Start Date:||December 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Positive Airway Pressure
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Device: Positive Airway Pressure
Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study.
Other Name: Philips Respironics Post-market PAP devices.
Active Comparator: Oral Appliance
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Device: Oral Appliance
Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device.
Other Name: mandibular advancement device
STAGE I, Part 1: We plan to extract limited access data sets from an existing research database (prior research patients' data from APPLES research project where patients consented to provide a limited accesses data set to the public domain as required by grants funded by the National Heart, Lung, and Blood Institute [NHLBI], PI: Kushida) and a dummy database with prepared test data (no real patient data) to evaluate and refine the initial iterations of the informatics infrastructure being created via an agile evolutionary development process (see COMET Project Map in Section 16).
STAGE I, Part 2: We would like to expand the functionality of the informatics infrastructure by testing its ability to incorporate research data collected from an electronic questionnaire, the Alliance Sleep Questionnaire (ASQ). Paper ASQ collection has been approved by the Stanford Institutional Review Board (IRB) and pilot collection successfully concluded in September 2010. We will enable data collection using an electronic version of ASQ in order to use these data to evaluate and refine the iterations for the informatics infrastructure. STAGE I, Part 3: We will expand the functionality of the informatics infrastructure by testing its ability to incorporate live (ongoing) longitudinal data collected from multiple forms and data sources obtained during the STAGE II study. The addition of these data will allow the COMET Steering Committee to create use cases with a greater diversity of data content. The STAGE II data will be used to evaluate and refine the iterations for the expanded informatics infrastructure. STAGE I, Part 4: Part 4 is designed to expand the collection of data beyond individual research studies, tapping into University-wide systems (e.g., Stride) to link longitudinal data collected during research studies to longitudinal data collected during clinical visits. Only de-identified data will be shared with the global network, and only the local site will hold the code book that will translate the Global ID to the Participant ID. All Health Insurance Portability and Accountability Act (HIPAA) regulations will be considered.
STAGE II: This stage is comprised of the multicenter, randomized, parallel group, comparative effectiveness trial to compare positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study will be incorporated in Part 3 of the STAGE I study. This comparative effectiveness trial will be conducted at 4 clinical centers, and the data collected during this trial will be used to test the electronic network informatics infrastructure.
Stage II CET Specific Aims:
- To evaluate and compare the effect of positive airway pressure and oral appliance therapy on 24-hour blood pressure and vascular structure and function associated with obstructive sleep apnea in a primarily female, overweight/obese hypertensive population.
- To evaluate and compare the effect of positive airway pressure and oral appliance therapy on sleep-disordered breathing, sleepiness, mood, and quality of life.
- To compare the cost-effectiveness of positive airway pressure and oral appliance as obstructive sleep apnea treatments.
- To explore cardiovascular biomarkers before and after treatment and to identify genetic polymorphisms which may predict treatment response.
STAGE III: This stage is comprised of completion of data analysis and preparation of the electronic network informatics infrastructure for deployment beyond the four Clinical Centers to interested Clinical and Translational Science Awards (CTSA) institutions. We will also explore expanding the ontologies beyond a sleep-related ontology to other medical ontologies, and the use of federated database methodology.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461473
|United States, California|
|Stanford University, Center for Human Sleep Research|
|Redwood City, California, United States, 94063|
|United States, Massachusetts|
|Harvard Brigham and Women|
|Boston, Massachusetts, United States, 02115|
|United States, Pennsylvania|
|Center for Sleep, University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Wisconsin|
|University of Wisconsin-Madison School of Medicine, Department of Psychiatry|
|Madison, Wisconsin, United States, 53719|
|Study Director:||Clete A Kushida, MD, PhD.||Stanford University|
|Principal Investigator:||Allan Pack, MD||Center for Sleep, University of Pennsylvania School of Medicine|
|Principal Investigator:||Susan Redline, MD||Harvard Brigham and Women|
|Principal Investigator:||Ruth Benca, MD||University of Wisconsin-Madison School of Medicine, Department of Psychiatry|