Sleep and Cardiovascular Health in Adolescence

NCT03727906 | Completed

• 1 other identifier: 50116
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Type; Sleep Disorder

Keywords

Cardiovascular; Blood Pressure; ECG; EEG

Outcome Measures

Primary Outcomes (2)

• Average nocturnal heart rate (HR), as a measure of cardiac contractility

  Heart rate (HR) response to experimental manipulation

  Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)

• Average nocturnal Pre-ejection period (PEP), as a measure of cardiac sympathetic activity

  Pre-ejection period (PEP) response to experimental manipulation

  Measured during 1 night (each for baseline, pre-sleep stress and pre-sleep relaxation conditions)

Study Arms (2)

Non-insomnia Group

OTHER

Non-insomnia participants will not meet criteria for current DSM-5 Insomnia Disorder or have a past history of insomnia. Interventions (order is randomly assigned): 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night 3. pre-sleep arousal up-regulation night.

Other: No pre-sleep arousal manipulation; Other: pre-sleep arousal down-regulation; Other: pre-sleep arousal up-regulation

Insomnia Group

OTHER

Insomnia Group participants will have to meet DSM-5 criteria for current Insomnia Disorder. Interventions (order is randomly assigned): 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night 3. pre-sleep arousal up-regulation night.

Other: No pre-sleep arousal manipulation; Other: pre-sleep arousal down-regulation; Other: pre-sleep arousal up-regulation

Interventions

No pre-sleep arousal manipulation OTHER

As with the pre-sleep arousal up- and down-regulation nights, the participant will sleep in comfortable sound-proof and temperature-controlled bedroom and will go to bed and wake up at his/her self-reported usual school-week times. On this night, pre-sleep activities include watching television or reading a book.

Also known as: Baseline

Insomnia Group; Non-insomnia Group

pre-sleep arousal down-regulation OTHER

On the "low pre-sleep arousal night", about 30 min before lights-out, a 20 min session of relaxation-driven Virtual Reality (VR) + slow breathing will be conducted. Adolescents will be instructed to perform slow diaphragmatic breathing and to let the VR immersion guide them through this relaxation process.

Also known as: pre-sleep relaxation

Insomnia Group; Non-insomnia Group

pre-sleep arousal up-regulation OTHER

On the "high pre-sleep arousal" night, an anticipatory stress procedure from the Trier Social Stress Test (TSST) will be used to elicit stress-induced ANS activation in the pre-sleep period. About 30 min before lights-out participants will be told that the following morning they will need to prepare and give a 5-min speech in front of a panel of assessors who will judge their performance and ask questions. Participants will be shown the testing room (set up with chairs, video camera, microphone).

Also known as: pre-sleep stress

Insomnia Group; Non-insomnia Group

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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)
• 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

Sponsors & Collaborators

• SRI International: lead

Study Sites (1)

SRI International

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: The experimental paradigm will consist of three in-lab counterbalanced non-consecutive (≥2 days in-between) polysomnography (PSG) nights in which we will modulate the level of pre-sleep psychophysiological arousal in a group of insomnia and non-insomnia adolescents. 1. no pre-sleep arousal manipulation night; 2. pre-sleep arousal down-regulation night (pre-sleep relaxation-driven Virtual reality ANS downregulation); 3. pre-sleep arousal up-regulation night (pre-sleep anticipation of stress using the Trier Social StressTest).

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 1, 2018
• Study Start: January 7, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 27, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

US (1)