Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03487991
Status:
UNKNOWN
Last Update Posted:
2018-04-04
First Post:
2018-03-28
Brief Title:
Stress Sleep and Cardiovascular Risk
Sponsor:
Howard University
Organization:
Howard University
Study Overview
Official Title:
Stress Sleep and Cardiovascular Risk
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors arterial stiffening and cardiovascular disease risk We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment and modifiable strategies for coping with sleep disruptive cognitions We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial
Detailed Description:
The study has 3 specific aims
Aim 1 To confirm the effects of neighborhood and posttraumatic stress and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers
Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence and nocturnalevening urinary noradrenergic excretion ratios
Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time and strategies for coping with sleep disruptive thoughts
Aim 2 To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction
Hypothesis 2 - Indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules and pulse wave velocity
Aim 3 To determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function
Hypothesis 3a - Reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep
Hypothesis 3b - Reduction of disruptive pre-sleep cognitions and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers
Aim 1 To confirm the effects of neighborhood and posttraumatic stress and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers
Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence and nocturnalevening urinary noradrenergic excretion ratios
Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time and strategies for coping with sleep disruptive thoughts
Aim 2 To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction
Hypothesis 2 - Indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules and pulse wave velocity
Aim 3 To determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function
Hypothesis 3a - Reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep
Hypothesis 3b - Reduction of disruptive pre-sleep cognitions and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None