Comparative Outcomes Management With Electronic Data Technology (COMET) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01461473
First received: October 20, 2011
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Sleep Apnea, Obstructive
Device: Positive Airway Pressure
Device: Oral Appliance
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: 2 months ] [ Designated as safety issue: Yes ]
    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:
  • Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: 2-6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Compare readings from flow-mediated vasodilatation (FMD) of the brachial artery.

  • Cardiovascular MRI (cMRI) [ Time Frame: 2-6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate the variance of number of lapses and mean reciprocal reaction time.

  • Epworth Sleepiness Scale (ESS) [ Time Frame: 2-6 months ] [ Designated as safety issue: Yes ]
    To compare the total score.

  • Profile of Mood States (POMS) [ Time Frame: 2-6 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 (FOSQ-10) [ Time Frame: 2-6 months ] [ Designated as safety issue: No ]
    To evaluate the overall score.

  • Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: 2-6 months ] [ Designated as safety issue: No ]
    To evaluate the overall SAQLI score.

  • Short Form-36 (SF-36) [ Time Frame: 2-6 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: 2-6 months ] [ Designated as safety issue: No ]
    To evaluate overall QWB-SA score


Other Outcome Measures:
  • Cost-effectiveness [ Time Frame: 2-6 months ] [ Designated as safety issue: No ]
    Quality-adjusted life years and units of utilization throughout the study

  • Treatment Efficacy [ Time Frame: 2-6 months ] [ Designated as safety issue: No ]
    Improvement of apnea-hypopnea index and oxygen desaturation index at treatment polysomnography


Enrollment: 196
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
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

Detailed 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.

  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 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, 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 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

Additional 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: September 19, 2014
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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014