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Completed

NCT Number: NCT05748496

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

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.

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Key information

Conditions

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menntaskolinn a Akureyri

Akureyri, 600, Iceland

About this study

The study is a prospective cross-sectional study implementing a brief behavioral and sleep hygiene education with mindfulness intervention in adolescents in the age-range of 16-19-years interested to participate and willing to sign a consent. Sleep duration, sleep timing and sleep quality will be measured with objective home sleep test for three (3) week-nights and two (2) weekend-nights and sleep, anxiety and depression symptoms will be evaluated with subjective questionnaires before starting the 4-week intervention. After the 4-week intervention sleep, anxiety and depression symptoms will be evaluated again using both the objective home sleep test and questionnaires to measure if the intervention improved sleep timing, duration and/or quality as well as symptoms of anxiety and depression.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Students interested to participate and able to sign enlightened consent

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 4-week intervention

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

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

    Time frame: 4-week intervention

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

Secondary outcomes

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

    Time frame: 4-week intervention

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

Sponsors and collaborators

Lead sponsor

Solveig Magnusdottir

Other Gov

Collaborators

  • MyCardioLLC

Registry information

Official study title

A Pilot Study to Evaluate Efficacy of Brief Behavioral and Sleep Hygiene Education With Mindfulness Intervention on Sleep Duration, Sleep Timing, Sleep Quality, Anxiety, Depression, and Quality of Life in Adolescents

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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