Comparative Outcomes Management With Electronic Data Technology (COMET) Study — COMET  

Sleep Apnea, Obstructive Clinical Trial

Official title: RO1: Comparative Outcomes Management With Electronic Data Technology (COMET) Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT01461473
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Completion date: June 2014