Overview

This trial is active, not recruiting.

Condition sleep apnea, obstructive
Treatments positive airway pressure device, oral appliances for osa
Phase phase 3
Sponsor Stanford University
Start date November 2010
End date April 2013
Trial size 238 participants
Trial identifier NCT01461473, 1R01 HS019738-01, SU-10182011-8536

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subjects randomized to standard clinical Positive Airway Pressure treatment of Obstructive Sleep Apnea.
positive airway pressure device Philips Respironics Post-market PAP devices.
Subjects who are randomized to PAP Treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study.
(Active Comparator)
Subjects randomized to standard oral appliances treatment of Obstructive Sleep Apnea.
oral appliances for osa Oral Appliances with thermo sensor.
Subjects who are randomized to OA Treatment Group will receive dental evaluation to determine the optimal setting for oral appliance.

Primary Outcomes

Measure
Nocturnal mean arterial blood pressure
time frame: 6-9 months

Secondary Outcomes

Measure
Percentage of patients who are classified as "non-dippers"
time frame: 6-9 months
Vascular ultrasound
time frame: 6-9 months
Cardiovascular MRI (Stanford Site Only)
time frame: 6-9 months
Cardiovascular / Inflammatory biomarkers
time frame: 6-9 months
Psychomotor Vigilance Task (PVT)
time frame: 6 - 9 months
Epworth Sleepiness Scale
time frame: 6 - 9 months
Profile of Mood State
time frame: 6 - 9 months
Functional Outcomes of Sleep Questionnaire - 10
time frame: 6 - 9 months
Sleep Apnea Quality of Life Index (SAQLI)
time frame: 6 - 9 months
SF-36
time frame: 6 -9 months
Quality of Well-Being Self-Administered Scale (QWB-SA)
time frame: 6 - 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title RO1: Comparative Outcomes Management With Electronic Data Technology (COMET) Study
Principal investigator Allan Pack, MD
Description STAGE I, Part 1: (Approved: 09NOV10) 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). Once Part 1 of the infrastructure is demonstrated and endorsed by the COMET Steering Committee, we will request Stanford IRB's approval before proceeding with Part 2 of the STAGE I study. STAGE I, Part 2: (Approved: 14DEC10) 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 ASQ. Paper ASQ collection has been approved by the Stanford IRB and pilot collection successfully concluded in September 2010. An updated protocol designed to allow the data collection using an electronic version of ASQ is currently under Stanford IRB review. Once approved, we will use these data to evaluate and refine the iterations for the informatics infrastructure. Once the additional features for Part 2 of the infrastructure are demonstrated and endorsed by the COMET Steering Committee, we will proceed with Part 3 of the STAGE I study. STAGE I, Part 3: (Approved: 09NOV10) 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. Recruitment of this target population is explained in STAGE II (see below). 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. Once the infrastructure with the Part 3 additions are demonstrated and endorsed by the COMET Steering Committee, we will request Stanford IRB's approval before proceeding with Part 4 of the STAGE I study. STAGE I, Part 4: (will request IRB approval later) 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 HIPAA regulations will be considered. Recruitment is required for Part 4 of the study, and will be done at the Stanford Sleep Medicine Center. We will also post flyers at the Stanford Hospital and Clinic to encourage patient participation. STAGE II: (Approved: 14DEC10) The STAGE II study is outlined in the COMET Research Plan. 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 II is a multi-site project. Recruitment is expected to begin in November 2011. 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 (4/1/13 - 9/30/13) 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Stanford University.