MedTrace Logo

Sleep and Cardiovascular Health in Adolescence

NCT03727906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-05-01

No results posted yet for this study

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

Interventions

OTHER

No pre-sleep arousal manipulation

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.

OTHER

pre-sleep arousal down-regulation

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.

OTHER

pre-sleep arousal up-regulation

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).

Sponsors & Collaborators

  • SRI International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2021-06-30
Completion
2022-08-27

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727906 on ClinicalTrials.gov