Clinical trial NCT01461473: Comparative Outcomes Management With Electronic Data Technology (COMET) Study
Official title: R01: Comparative Outcomes Management With Electronic Data Technology (COMET) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months
timeFrame: 2 months
Secondary outcomes:
measure: Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months
timeFrame: 6 months
measure: Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months
timeFrame: 2 months
measure: Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months
timeFrame: 6 months
measure: Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
timeFrame: 6 months
measure: Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
timeFrame: 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine Center
state: California
city: Boston
country: United States
facility: Harvard Brigham and Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Center for Sleep and Circadian Neurobiology, University of Pennsylvania School of Medicine
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine, Department of Psychiatry
state: Wisconsin
Study officials:
affiliation: Stanford University
name: Clete A Kushida, MD, PhD
role: STUDY_DIRECTOR
affiliation: Center for Sleep, University of Pennsylvania School of Medicine
name: Allan Pack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Brigham and Women's Hospital
name: Susan Redline, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin-Madison School of Medicine
name: Ruth Benca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
citation: Nichols DA, DeSalvo S, Miller RA, Jonsson D, Griffin KS, Hyde PR, Walsh JK, Kushida CA. The COMET Sleep Research Platform. EGEMS (Wash DC). 2014 Nov 24;2(1):1059. doi: 10.13063/2327-9214.1059. eCollection 2014.