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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clete A. Kushida, Stanford University
ClinicalTrials.gov Identifier:
NCT01461473
First received: October 20, 2011
Last updated: April 14, 2017
Last verified: April 2017
  Purpose

STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data.

STAGE II: This was 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 was incorporated in Part 3 of the STAGE I study.

STAGE III of the COMET study was completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We also explored expanding ontologies, and the use of federated database methodology.


Condition Intervention
Sleep Apnea, Obstructive Device: Positive Airway Pressure (PAP) Device: Oral Appliance (OA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: R01: Comparative Outcomes Management With Electronic Data Technology (COMET) Study

Resource links provided by NLM:


Further study details as provided by Clete A. Kushida, Stanford University:

Primary Outcome Measures:
  • Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months [ 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


Secondary Outcome Measures:
  • Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months [ Time Frame: 6 months ]
    Nocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment

  • Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months [ Time Frame: 2 months ]
    Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.

  • Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months [ Time Frame: 6 months ]
    Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.

  • Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound [ Time Frame: 6 months ]
    Mean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter [in millimeters] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit

  • Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound [ Time Frame: 6 months ]
    Mean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit


Enrollment: 131
Study Start Date: December 2011
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Positive Airway Pressure
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
Device: Positive Airway Pressure (PAP)
Participants randomized to the Positive Airway Pressure treatment group received adequate Positive Airway Pressure (PAP) pressure therapy by a PAP titration study and used the device for 6 months.
Other Name: Auto-titrating PAP (APAP), Continuous PAP (CPAP)
Active Comparator: Oral Appliance
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
Device: Oral Appliance (OA)
Participants randomized to the Oral Appliance treatment group received a dental evaluation to determine the optimal setting for the Oral Appliance (OA), and used the appliance for 6 months.
Other Name: Mandibular Advancement Device

Detailed Description:

STAGE I, Part 1: We extracted limited access data sets from an existing research database (prior research patients' data from APPLES research project, where patients consented to provide a limited access data sets to the public domain as required by grants funded by the National Heart, Lung, and Blood Institute [NHLBI], PI: Dr. Clete Kushida) and a dummy database with prepared test data (no real patient data) to evaluate and refine the initial iterations of the informatics infrastructure created via an agile evolutionary development process.

STAGE I, Part 2: We expanded the functionality of the informatics infrastructure by testing its ability to incorporate research data collected from an electronic questionnaire, the Alliance Sleep Questionnaire (ASQ). We enabled data collection using the ASQ in order to use these data to evaluate and refine the iterations for the informatics infrastructure.

STAGE I, Part 3: We expanded 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 allowed the COMET Steering Committee to create use cases with a greater diversity of data content. The STAGE II data were used to evaluate and refine the iterations for the expanded informatics infrastructure.

STAGE I, Part 4: Part 4 was 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 were shared with the network, and only the local site held the codebook that translated the Global Identifier (ID) to the Participant ID. All Health Insurance Portability and Accountability Act (HIPAA) regulations were considered.

STAGE II: This stage was 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 were incorporated in Part 3 of the STAGE I study. This comparative effectiveness trial was conducted at 4 clinical centers, and the data collected during this trial were used to test the electronic network informatics infrastructure. The primary aim of the Stage II CET was 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.

STAGE III: This stage was 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 also explored expanding the ontologies beyond a sleep-related ontology to other medical ontologies, and the use of federated database methodology.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • BMI > = 25.0 kg/m^2.
  • A diagnosis of obstructive sleep apnea based upon medical history and apnea- hypopnea index > = 10.0 or oxygen desaturation index (ODI; ≥4%) ≥ 10.0 on Diagnostic Polysomnogram.
  • Report a history of hypertension (or need for treatment for hypertension) which is currently untreated OR taking medication for the treatment of hypertension.
  • Stable medication regimen for 2 months prior to the Baseline Testing Visit. As-needed medications such as those used for allergy, cold, or minor pain symptoms may be used at the discretion of the Clinical Center physician.

Exclusion Criteria:

  • Cardiovascular disease which, in the judgment of the investigator, if observed during standard clinical practice would lead the treating physician to make every effort to treat the patient's sleep apnea with positive airway pressure, rather than alternative treatments.
  • Clinically significant acute or chronic disease that is not well controlled or could affect ability to complete or comply with study procedures, in the opinion of the Clinical Center physician.
  • Respiratory disease requiring supplemental oxygen or medication. Individuals with asthma may be included at the discretion of the Clinical Center physician if disease is well controlled and medications are stable for 2 months.
  • History of (within 12 months prior to enrollment), or current diagnosis of, Axis I or Axis II psychiatric disorder (other than obstructive sleep apnea) that in the opinion of the Clinical Center physician would affect ability to complete or comply with study procedures (e.g., schizophrenia and other psychotic disorders).
  • History of (within 3 months prior to enrollment), or current diagnosis of narcolepsy, idiopathic hypersomnia, restless legs syndrome, rapid eye movement (REM) behavior disorder, persistent situational insomnia, or sleep-related breathing disorders other than obstructive sleep apnea.
  • Periodic limb movement arousal index > 10.0 on the Diagnostic Polysomnogram.
  • Significant daytime sleepiness at study entry as indicated by:

    • an Epworth Sleepiness Scale total score > 16, or a score of 3 (high chance) on the question about risk of dozing "In a car, while stopped for a few minutes in traffic" or
    • a report of falling asleep at the wheel, a motor vehicle accident, or near-miss accident due to sleepiness in the past 24 months, which in the judgment of the study physician was not attributable to acute sleep loss.
  • Oxygen saturation < 80% for > 10% of sleep time during the Diagnostic Polysomnogram, or intervention with positive airway pressure or oxygen for safety purposes during the Diagnostic Polysomnogram.
  • Any prior treatment for obstructive sleep apnea with positive airway pressure or oral appliance, or surgical treatment for obstructive sleep apnea in the past year.
  • Contraindication for treatment with either positive airway pressure or oral appliance, in the opinion of the Clinical Center physician or dentist, including significant nasal obstruction, insufficient or loose teeth, dentures, advanced periodontal disease, or significant temporomandibular joint pain.
  • Pregnancy.
  • Difficulty understanding or speaking English, or inability to read and understand informed consent and study procedures.
  • Significant vision, hearing, or motor problems that, in the opinion of the Clinical Center physician, would affect ability to complete study procedures.
  • A work schedule that does not allow for nighttime sleep on the 3 nights before each study visit.
  • Current or planned participation in another research study.
  • Metal objects, devices, or implants that are in or on the body (Stanford Clinical Center only).
  • Creatinine clearance <30 and creatinine >1.6 (Stanford Clinical Center only).
  • Upper arm circumference > 20 inches
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461473

Locations
United States, California
Stanford Sleep Medicine Center
Redwood City, California, United States, 94063
United States, Massachusetts
Harvard Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Center for Sleep and Circadian Neurobiology, 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
Sponsors and Collaborators
Stanford University
Investigators
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's Hospital
Principal Investigator: Ruth Benca, MD University of Wisconsin-Madison School of Medicine
  More Information

Publications:
Responsible Party: Clete A. Kushida, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01461473     History of Changes
Other Study ID Numbers: SU-10182011-8536
1R01HS019738-01 ( US NIH Grant/Contract Award Number )
Study First Received: October 20, 2011
Results First Received: December 8, 2016
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Clete A. Kushida, Stanford University:
Obstructive Sleep Apnea
Obstructive Sleep Apnea Syndrome
Sleep Apnea Syndrome, Obstructive
Syndrome, Obstructive Sleep Apnea
Syndrome, Sleep Apnea, Obstructive
Syndrome, Upper Airway Resistance, Sleep Apnea
Upper Airway Resistance Sleep Apnea Syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 27, 2017