Comparative Outcomes Management With Electronic Data Technology (COMET) Study

NCT01461473 | Completed Results DMC

• 2 other identifiers: SU-10182011-85361R01HS019738-01
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months

  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

Secondary Outcomes (5)

• Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months

  6 months

• Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months

  2 months

• Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months

  6 months

• Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound

  6 months

• Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound

  6 months

Study Arms (2)

Positive Airway Pressure

ACTIVE COMPARATOR

Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).

Device: Positive Airway Pressure (PAP)

Oral Appliance

ACTIVE COMPARATOR

Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).

Device: Oral Appliance (OA)

Interventions

Positive Airway Pressure (PAP) DEVICE

Participants randomized to the Positive Airway Pressure treatment group received adequate Positive Airway Pressure (PAP) pressure therapy by a PAP titration study and used the device for 6 months.

Also known as: Auto-titrating PAP (APAP), Continuous PAP (CPAP)

Positive Airway Pressure

Oral Appliance (OA) DEVICE

Participants randomized to the Oral Appliance treatment group received a dental evaluation to determine the optimal setting for the Oral Appliance (OA), and used the appliance for 6 months.

Also known as: Mandibular Advancement Device

Oral Appliance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (4)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Location

Harvard Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Center for Sleep and Circadian Neurobiology, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin-Madison School of Medicine, Department of Psychiatry

Madison, Wisconsin, 53719, United States

Location

Related Publications (2)

• 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.

  PMID: 8464434 BACKGROUND

• 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.

  PMID: 25848590 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Clete A. Kushida, M.D., Ph.D.
• Organization: Stanford University

clete@stanford.edu

650-721-7560

Study Officials

• Clete A Kushida, MD, PhD

  Stanford University

  STUDY DIRECTOR

• Allan Pack, MD

  Center for Sleep, University of Pennsylvania School of Medicine

  PRINCIPAL INVESTIGATOR

• Susan Redline, MD

  Harvard Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Ruth Benca, MD

  University of Wisconsin-Madison School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 28, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)