Ignite Creation Date:
2024-05-06 @ 12:17 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03727906
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2018-10-25
Brief Title:
Sleep and Cardiovascular Health in Adolescence
Sponsor:
SRI International
Organization:
SRI International
Study Overview
Official Title:
Sleep and Cardiovascular Health in Adolescence
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
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:
Insomnia is a prevalent and under-recognized disorder in adolescence particularly in girls with long-term repercussions for mental and physical health This study assesses manifestation of autonomic hyperarousal and vulnerability to insomnia using a sample of male and female adolescents with and without Diagnostic and Statistical Manual DSM-5 Insomnia Disorder Outcomes from this study have the potential to inform prevention and treatment interventions for insomnia that can be implemented at a young age before chronic negative sequelae of this common disorder manifest
Detailed Description:
Insomnia is highly prevalent in adolescence particularly in post-pubertal girls and tends to persist over time Insomnia is considered a hyperarousal disorder in which abnormally elevated levels of cognitive and physiological activation particularly evident at bed-time prevent individuals from falling asleep and having a restorative nights sleep Hyperarousal is a major pathophysiological mechanism linking insomnia with poor mental and physical health including cardiovascular CV disease The investigators and others have shown evidence of autonomic nervous system ANS dysfunction such as hyperactivation of the sympathetic branch of the ANS - a major etiological factor in CV disease - in young and midlife adults both before and during sleep It is unknown if ANS hyperarousal is evident in adolescents with insomnia
The biological basis for an emerging sex difference in insomnia prevalence in adolescence is unknown The investigators pilot data reveal intriguing evidence of sex-differences in basic and stress-dependent ANS modulation during sleep in adolescents with girls showing a greater ANS response to stress These data suggest the existence of a predisposing and stress-dependent ANS vulnerability in female adolescents a potential pathway to develop insomnia This study takes a novel approach to investigating the manifestation of physiological ANS and CV hyperarousal in adolescents with insomnia by experimentally manipulating the pre-sleep arousal state via stress-induced ANS up-regulation and relaxation-driven ANS down-regulation In addition the study focuses on sex differences in ANS and CV responses to pre-sleep ANS manipulation potentially addressing the question of why female sex is a major risk factor for insomnia
The investigators aim to test 110 male and female high-school students 16-20y with and without DSM-5 Insomnia Disorder during a regular in-lab polysomnographic night baseline and under experimental pre-sleep stress psychosocial stressor and pre-sleep relaxation Virtual reality ANS bio-feedback intervention nights using state-of-the-art noninvasive beat-to-beat ANS and CV measures including blood pressure to assess nocturnal ANS and CV function in adolescents with insomnia Aim 1 the impact of pre-sleep ANS arousal levels on nocturnal ANS and CV function and sleep in adolescents with and without insomnia considering possible sex differences Aim 2 and the extent to which nocturnal ANS and CV function mediate the effect of pre-sleep arousal levels on objective and perceived sleep quality Aim 3
This study has the potential to elucidate pathophysiological ANS hyperarousal underlying Insomnia Disorder in adolescence including potential reasons for the vulnerability to insomnia in girls leading to better recognition and potentially new treatment strategies of this disorder targeted at the state of ANS hyperarousal in the pre-sleep period
The biological basis for an emerging sex difference in insomnia prevalence in adolescence is unknown The investigators pilot data reveal intriguing evidence of sex-differences in basic and stress-dependent ANS modulation during sleep in adolescents with girls showing a greater ANS response to stress These data suggest the existence of a predisposing and stress-dependent ANS vulnerability in female adolescents a potential pathway to develop insomnia This study takes a novel approach to investigating the manifestation of physiological ANS and CV hyperarousal in adolescents with insomnia by experimentally manipulating the pre-sleep arousal state via stress-induced ANS up-regulation and relaxation-driven ANS down-regulation In addition the study focuses on sex differences in ANS and CV responses to pre-sleep ANS manipulation potentially addressing the question of why female sex is a major risk factor for insomnia
The investigators aim to test 110 male and female high-school students 16-20y with and without DSM-5 Insomnia Disorder during a regular in-lab polysomnographic night baseline and under experimental pre-sleep stress psychosocial stressor and pre-sleep relaxation Virtual reality ANS bio-feedback intervention nights using state-of-the-art noninvasive beat-to-beat ANS and CV measures including blood pressure to assess nocturnal ANS and CV function in adolescents with insomnia Aim 1 the impact of pre-sleep ANS arousal levels on nocturnal ANS and CV function and sleep in adolescents with and without insomnia considering possible sex differences Aim 2 and the extent to which nocturnal ANS and CV function mediate the effect of pre-sleep arousal levels on objective and perceived sleep quality Aim 3
This study has the potential to elucidate pathophysiological ANS hyperarousal underlying Insomnia Disorder in adolescence including potential reasons for the vulnerability to insomnia in girls leading to better recognition and potentially new treatment strategies of this disorder targeted at the state of ANS hyperarousal in the pre-sleep period
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?:
False
Is an FDA AA801 Violation?:
None