Study to Evaluate Efficacy of Brief Behavioral and Sleep Hygiene Education With Mindfulness Intervention on Sleep Quality

NCT05748496 | Completed

• 1 other identifier: VSN-22-174
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep plays a fundamental role in both mental- and physical-health, with good sleep health including adequate duration and quality, appropriate timing, regularity, and absence of sleep disorders. The purpose of this study is to evaluate sleep in adolescent and if brief behavioral and sleep hygiene education with mindfulness intervention improves, sleep timing, sleep duration, sleep quality, anxiety/depression, and quality of life. During adolescence extensive physiological changes happen that make it easier for adolescents to stay up later, that may increase the time it may take them to fall-asleep and developing insomnia symptoms. At the same time psychosocial changes happen, that may may even have been further amplified in the last decade, with increase in social media use and evening screen-time. As sleep need is not decreased and with adolescents having to wake up at "socially acceptable times" rather than the endogenous sleep offset time, sleep duration may be shortened causing chronic sleep loss and daytime sleepiness. Insufficient sleep in adolescents may affect their daytime functioning, causing fatigue and memory issues, affect school attendance and academic performance, affect mood, mental- and physical health, cause behavioral dysfunction and has been associated with worse health outcomes, adverse risk behaviors and even increase risk for accidents.This study should advance understanding of sleep in adolescents and if this simple interventions can be effective in improving their sleep and mental health. If effective larger studies will be needed to evaluate if there might be a value in implementing changes in the infrastructure of the educational system to better support sleep and mental health of adolescent.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• To evaluate if changes will be observed in sleep quality measured with sleep quality index (SQI)

  Intervention with brief behavioral and sleep hygiene education and mindfulness training with breathing exercises and Yoga Nidra

  4-week intervention

• To evaluate if changes will be observed in sleep timing and duration (hours, minutes)

  Intervention with brief behavioral and sleep hygiene education and mindfulness training with breathing exercises and Yoga Nidra

  4-week intervention

Secondary Outcomes (1)

• To evaluate if changes will be observed in anxiety evaluated using the General Anxiety Disorder-7 scale (score 0-21)

  4-week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Brief behavioral sleep therapy, sleep hygiene education and mindfulness training

Controle

NO INTERVENTION

Interventions

Brief behavioral sleep therapy, sleep hygiene education and mindfulness training BEHAVIORAL

Brief behavioral sleep therapy, sleep hygiene education and mindfulness training using breathing exercises and Yoga Nidra

Intervention

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students interested to participate and able to sign enlightened consent

You may not qualify if:

• Atrial fibrillation or ventricular trigeminy Severe and uncontrolled asthma or severe pulmonary disease Moderate and severe obstructive sleep apnoea (OSA)

Sponsors & Collaborators

• Solveig Magnusdottir: lead
• MyCardioLLC: collaborator

Study Sites (1)

Menntaskolinn a Akureyri

Akureyri, 600, Iceland

Location

Study Officials

• Solveig Magnusdottir, MD

  MyCardioLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 28, 2023
• Study Start: February 20, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)