Effect of Continuous Positive Airway Pressure (CPAP) Therapy on Changes of Blood Pressure Between Day and Night
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01865864|
Recruitment Status : Terminated (Difficulty Recruiting subjects)
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
|Condition or disease|
|Obstructive Sleep Apnea Diurnal Blood Pressure|
To investigate the effect of CPAP therapy on the restoration of the normal diurnal blood pressure pattern. Possible improvement of the circadian dipper pattern after CPAP therapy, with or without a decrease in the mean blood pressure, might constitute an additional potential benefit of CPAP therapy in reducing cardiovascular risk in patients with OSA.
STUDY DESIGN AND METHODS:
Patients diagnosed with OSA at the sleep center will undergo blood pressure monitoring by measuring the blood pressure every half hour during sleep study. Patients with normal circadian BP changes are treated with CPAP as indicated. Patients with non-dipping BP pattern will be approach to join our study. The patients will receive CPAP therapy. The trial period will be 6 weeks. At the end of the trial, the patients from both treatment arms will undergo a second BP monitoring according to our above-mentioned protocol (systolic, diastolic and mean BP) to determine the circadian BP changes. Apnea-Hypopnea index will be calculated to reflect on the compliance with our therapy. Thus, patients could be divided into two study groups according to their objective compliance.
Baseline population characteristics between the placebo group and CPAP group will be noted. These include apnea-hypopnea index (AHI), medications, other co morbidities and other factors that might affect the normal circadian BP dipping pattern including factors affecting the volume status i.e. diabetes, renal failure, uncontrolled diabetes. Any new medications added during the 6 weeks trial period will be noted.
The difference in daytime and nighttime BP pattern will be noted between the treated (CPAP) and the non-compliant groups. The circadian BP variation will be recorded in both groups. Changes in the circadian BP pattern will be assessed on an intention-to-treat basis. The odds ratio, p value and confidence interval will be calculated. Correlation between the dipping/non-dipping pattern with CPAP compliance, severity of OSA and number of antihypertensive drugs will be studied as well
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||Changes In Diurnal Blood Pressure Pattern In Obstructive Sleep Apnea (OSA) Patients After CPAP Therapy|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Compliant with CPAP
noncompliant with CPAP
- drop of Blood pressure at night [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865864
|United States, New York|
|Staten Island, New York, United States, 10305|
|Principal Investigator:||Suzzane El-Sayegh, MD||Staten Island University Hospital|