Sleep and Cardiovascular Health in Adolescence

Completed · Not applicable

Conditions studied: Insomnia Type; Sleep Disorder

In brief

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.

Key facts

Study ID

NCT03727906

Run by

SRI International

People needed

115

Starts

2019-01-07

Expected to finish

2022-08-27

Last updated by the study team

2023-05-01

Who can join

Age: 16 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be post-pubertal
• BMI <30 kg/m-2 to reduce the likelihood of obesity-related sleep-disordered breathing

You may not qualify if…

• Current use of drugs known to affect sleep and CV systems (e.g., Antidepressants, stimulants, beta-blockers)
• Serious history of, or current medical conditions that could affect brain function, or study participation, including Diabetes, cancer, neurological diseases (e.g., Seizure disorders) recurrent migraine, cardiovascular diseases (e.g., Hypertension) and traumatic brain injury with loss of consciousness >30 minutes
• Current DSM-5 diagnosis of Neurodevelopmental Disorders (e.g., Attention-Deficit/Hyperactivity Disorder)
• Current DSM-5 diagnosis of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders
• Current DSM-5 diagnosis of Depressive and Anxiety Disorders (e.g., Major Depressive Disorder)
• Current DSM-5 diagnosis of Post-Traumatic Stress Disorder
• Current DSM-5 diagnosis of Substance-Related and Addictive Disorders (e.g., Alcohol Use Disorder)
• History of and persistence in severe learning disorder, pervasive developmental disorder, or other condition requiring repeated or persistent specialized education (e.g., Estimated intellectual quotient (IQ) >2 standard deviations below mean)
• Current psychiatric disorders in both control and insomnia groups is exclusionary
• Past history of psychiatric disorders in controls is exclusionary (past history of psychiatric disorders in the insomnia group is not exclusionary)
• Shift work in the previous year and no time-zone travel in the past month
• Evidence of other DSM-5 Sleep-Wake Disorders (e.g., Narcolepsy), Breathing-Related Sleep Disorders (e.g., Obstructive Sleep Apnea Hypopnea, Circadian Rhythm Sleep-Wake Disorders and particularly Delayed Sleep Phase Type), and Parasomnias (e.g., Non-Rapid Eye Movement Sleep Arousal Disorders, Rapid Eye Movement Sleep Behavior Disorder and Restless Legs Syndrome)
• Current pregnancy

Where it is running

• SRI International — Menlo Park, California, United States

Full record on ClinicalTrials.gov

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