Comparative Outcomes Management With Electronic Data Technology (COMET) Study

Sleep Apnea, Obstructive Clinical Trial

— COMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461473
• Other study ID #: SU-10182011-8536
• Secondary ID: 1R01HS019738-01
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2011
• Last updated: September 19, 2014
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Harvard Brigham and Women	Boston	Massachusetts
United States	University of Wisconsin-Madison School of Medicine, Department of Psychiatry	Madison	Wisconsin
United States	Center for Sleep, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania
United States	Stanford University, Center for Human Sleep Research	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	Quality-adjusted life years and units of utilization throughout the study	2-6 months	No
Other	Treatment Efficacy	Improvement of apnea-hypopnea index and oxygen desaturation index at treatment polysomnography	2-6 months	No
Primary	Nocturnal mean arterial blood pressure	Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment	2 months	Yes
Secondary	Ambulatory Blood Pressure Monitoring (ABPM)	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	2-6 months	Yes
Secondary	Vascular Ultrasound (VU)	Compare readings from flow-mediated vasodilatation (FMD) of the brachial artery.	2-6 months	No
Secondary	Cardiovascular MRI (cMRI)	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).	2-6 months	No
Secondary	Cardiovascular / Inflammatory Biomarkers	To explore C-reactive protein (CRP), tumor necrosis factor-alpha (TNFa), and interleukin-6 (IL-6).	2-6 months	No
Secondary	Psychomotor Vigilance Task (PVT)	To evaluate the variance of number of lapses and mean reciprocal reaction time.	2-6 months	No
Secondary	Epworth Sleepiness Scale (ESS)	To compare the total score.	2-6 months	Yes
Secondary	Profile of Mood States (POMS)	To evaluate the total mood disturbance score and score on the fatigue-inertia subscale.	2-6 months	No
Secondary	Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)	To evaluate the overall score.	2-6 months	No
Secondary	Sleep Apnea Quality of Life Index (SAQLI)	To evaluate the overall SAQLI score.	2-6 months	No
Secondary	Short Form-36 (SF-36)	To evaluate the role-physical scale and vitality scale scores.	2-6 months	No
Secondary	Quality of Well-Being Self-Administered Scale (QWB-SA)	To evaluate overall QWB-SA score	2-6 months	No