Comparative Outcomes Management With Electronic Data Technology (COMET) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01461473
First received: October 20, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

STAGE I of the COMET study is to develop an Electronic Data Network 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 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 scope of the COMET study and exploration of deployment beyond the four CCs to interested CTSA institutions. We will also explore expanding the ontologies beyond a sleep medicine ontology to other medical ontologies.


Condition Intervention Phase
Sleep Apnea, Obstructive
Device: Positive Airway Pressure Device
Device: Oral Appliances for OSA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RO1: Comparative Outcomes Management With Electronic Data Technology (COMET) Study

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Nocturnal mean arterial blood pressure [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of patients who are classified as "non-dippers" [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
    To compare systolic blood pressure (SBP), diastolic blood pressure (DBP), or mean arterial blood pressure readings from 24-hour blood pressure monitoring of pre- and post-treatment phases.

  • Vascular ultrasound [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
    Compare readings from flow-mediated vasodilatation (FMD) of the brachial artery.

  • Cardiovascular MRI (Stanford Site Only) [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
    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: 6-9 months ] [ Designated as safety issue: No ]
    To explore C-reactive protein (CRP), tumor mecrosis factor-alpha (TNFa), interleukin-6 (IL-6).

  • Psychomotor Vigilance Task (PVT) [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
    To evaluate the variance of number of lapses and mean reciprocal reaction time.

  • Epworth Sleepiness Scale [ Time Frame: 6 - 9 months ] [ Designated as safety issue: Yes ]
    To compare the total score.

  • Profile of Mood State [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
    To evaluate the total mood disturbance score and score on the fatigue-inertia subscale.

  • Functional Outcomes of Sleep Questionnaire - 10 [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
    To evaluate the overall score.

  • Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
    To evaluate the overall SAQLI score.

  • SF-36 [ Time Frame: 6 -9 months ] [ Designated as safety issue: No ]
    To evaluate the role-physical scale and vitality scale scores.

  • Quality of Well-Being Self-Administered Scale (QWB-SA) [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
    To evaluate overall QWB-SA score


Estimated Enrollment: 238
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PAP Treatment for OSA
Subjects randomized to standard clinical Positive Airway Pressure treatment of Obstructive Sleep Apnea.
Device: Positive Airway Pressure Device
Subjects who are randomized to PAP 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: OA Treatment for OSA
Subjects randomized to standard oral appliances treatment of Obstructive Sleep Apnea.
Device: Oral Appliances for OSA
Subjects who are randomized to OA Treatment Group will receive dental evaluation to determine the optimal setting for oral appliance.
Other Name: Oral Appliances with thermo sensor.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • BMI > = 25.0 kg/m2.
  • A diagnosis of obstructive sleep apnea based upon medical history and apnea- hypopnea index > = 10.0 on Diagnostic Polysomnogram.
  • Report a history of hypertension
  • Stable medication regimen for 2 months prior to study entry.

Exclusion Criteria:

  • History or clinical symptoms of congestive heart failure, coronary artery disease, angina, myocardial infarction, stroke, Raynaud's disease, or cardiac rhythm disturbance
  • 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.
  • History of (within 12 months prior to enrollment), or current diagnosis of, Axis I or Axis II psychiatric disorder
  • History of (within 3 months prior to enrollment), or current diagnosis of narcolepsy, idiopathic hypersomnia, restless legs syndrome, 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.
  • Prior treatment for obstructive sleep apnea with positive airway pressure, surgery, or oral appliance.
  • Contraindication for treatment with either positive airway pressure or oral appliance.
  • 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.
  • Night shift work or rotating shift schedule that includes night shift.
  • Current or planned participation in another research study.
  • Metal objects, devices, or implants that are in or on the body, including pacemakers and aneurysm clips, prostheses, and any other non-removable metallic objects embedded in the body such as bullets, buckshot, shrapnel, and any metal fragments from working around metal; tattoos; allergy to gadolinium contrast agents (Stanford Clinical Center only).
  • Creatinine clearance <30 and creatinine >1.6 (Stanford Clinical Center only).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461473

Locations
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
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
Principal Investigator: Ruth Benca, MD University of Wisconsin-Madison School of Medicine, Department of Psychiatry
  More Information

Publications:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01461473     History of Changes
Other Study ID Numbers: SU-10182011-8536, 1R01 HS019738-01
Study First Received: October 20, 2011
Last Updated: October 26, 2011
Health Authority: United States: Federal Government

Keywords provided by 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:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014