Trial Outcomes & Findings for Comparative Outcomes Management With Electronic Data Technology (COMET) Study (NCT NCT01461473)
NCT ID: NCT01461473
Last Updated: 2017-05-17
Results Overview
Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
2 months
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
Positive Airway Pressure
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
59
|
|
Overall Study
COMPLETED
|
67
|
55
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Outcomes Management With Electronic Data Technology (COMET) Study
Baseline characteristics by cohort
| Measure |
Positive Airway Pressure
n=72 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=59 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.85 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
52.61 years
STANDARD_DEVIATION 9.84 • n=7 Participants
|
53.84 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
59 participants
n=7 Participants
|
131 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: 31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.
Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment
Outcome measures
| Measure |
Positive Airway Pressure
n=36 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=26 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months
|
82.1 mmHg
Standard Deviation 7.79
|
84.3 mmHg
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: 6 monthsNocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment
Outcome measures
| Measure |
Positive Airway Pressure
n=67 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=55 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months
|
83.1 mmHg
Standard Deviation 9.63
|
84.7 mmHg
Standard Deviation 9.59
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: 31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.
Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.
Outcome measures
| Measure |
Positive Airway Pressure
n=36 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=26 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months
|
86.8 percentage of NMAP to daytime MAP
Standard Deviation 7.07
|
87.0 percentage of NMAP to daytime MAP
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Two participants in the PAP arm and 1 participant in the OA arm did not have sufficient daytime MAP data to calculate the ratio of NMAP to daytime MAP at 6 months
Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.
Outcome measures
| Measure |
Positive Airway Pressure
n=65 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=54 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months
|
86.6 percentage of NMAP to daytime MAP
Standard Deviation 8.18
|
87.9 percentage of NMAP to daytime MAP
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: 6 monthsMean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter \[in millimeters\] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit
Outcome measures
| Measure |
Positive Airway Pressure
n=67 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=55 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
|
0.009 mm
Standard Deviation 0.0165
|
0.012 mm
Standard Deviation 0.0196
|
SECONDARY outcome
Timeframe: 6 monthsMean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit
Outcome measures
| Measure |
Positive Airway Pressure
n=67 Participants
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=55 Participants
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
|
2.63 percent change
Standard Deviation 4.550
|
3.51 percent change
Standard Deviation 5.637
|
Adverse Events
Positive Airway Pressure
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Oral Appliance
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Positive Airway Pressure
n=72 participants at risk
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=59 participants at risk
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
Cardiac disorders
Non-ST elevated myocardial infarction (NSTEMI)
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Nervous system disorders
Death-Acute Ischemic Stroke-Right Hemispheric Infarct
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Nervous system disorders
Acute Hemorrhagic Stroke (Intraventricular Hemorrhage)
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgeries for Breast Cancer
|
1.4%
1/72 • Number of events 2 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Reproductive system and breast disorders
Hyserectomy
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
General disorders
Dizziness
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
Other adverse events
| Measure |
Positive Airway Pressure
n=72 participants at risk
Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).
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
n=59 participants at risk
Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).
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.
|
|---|---|---|
|
General disorders
Motor Vehicle Accident
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
1.7%
1/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Musculoskeletal and connective tissue disorders
Injury/Pain in Extremities
|
4.2%
3/72 • 6 months per patient
Standardized questionnaire at each visit
|
13.6%
8/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Blood and lymphatic system disorders
Hemodialysis catheter dislodgement
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
1.7%
1/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
3.4%
2/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Infections and infestations
Sinusitis
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
3.4%
2/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Skin and subcutaneous tissue disorders
Benign Skin Cyst Removal
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
1.7%
1/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Musculoskeletal and connective tissue disorders
Tooth/Jaw Pain
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
6.8%
4/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Nervous system disorders
Headache/Migraine
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
1.7%
1/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Infections and infestations
Upper Respiratory Infection/Discomfort
|
4.2%
3/72 • 6 months per patient
Standardized questionnaire at each visit
|
16.9%
10/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Infections and infestations
Tooth Extraction
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
1.7%
1/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Nervous system disorders
Spondylosis/Back Pain
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
5.1%
3/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/72 • 6 months per patient
Standardized questionnaire at each visit
|
1.7%
1/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Psychiatric disorders
Worsened Depression
|
2.8%
2/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Gastrointestinal disorders
Abdominal Pain/Gastroenteritis
|
5.6%
4/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Eye disorders
Cataract Surgery
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Gastrointestinal disorders
Esophageal Reflux
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Cardiac disorders
Increased High Blood Pressure
|
5.6%
4/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Skin and subcutaneous tissue disorders
Basal Cell Carcinoma Surgery
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Skin and subcutaneous tissue disorders
Nasal Skin Irritation
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/72 • 6 months per patient
Standardized questionnaire at each visit
|
0.00%
0/59 • 6 months per patient
Standardized questionnaire at each visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place