Montana State University
Bozeman, Montana, 59717, United States
NCT Number: NCT03567434
This study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. Our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.
Looking for future studies?
Notify Me21 year–40 year
All sexes
Interventional
Not applicable
Bozeman, Montana, 59717, United States
This study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. The study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). All subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. Both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. Finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (CPAP) or sham-CPAP for one additional night of evening alcohol consumption.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
Other names: Ethanol
Time frame: 1 month
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.
Time frame: 1 month
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity.
Time frame: 1 month
The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins.
Time frame: 1 month
Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.
Time frame: 1 month
Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.
Time frame: 1 month
The change in muscle sympathetic nerve activity during an acute laboratory stressor.
Baylor University
Other
Randomized, Double-Blind, Placebo-Based Study to Determine Effect of Evening Alcohol on Sympathetic Neural Activity and Baroreflex Function in Binge Drinkers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07675447
Alcohol Drinking, Alcohol-Related Disorders
São Paulo, Brazil
View Trial DetailsNCT05369169
Alcohol Drinking, Alcohol-Related Disorders
New Brunswick, New Jersey, United States
View Trial DetailsNCT02794311
Alcohol Drinking, Alcohol-Related Disorders
Reims, France
View Trial DetailsNCT01546025
Alcohol Drinking, Alcohol-Related Disorders
View Trial Details