Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents

NCT ID: NCT06028997

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-06-19

Brief Summary

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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- and depression symptoms.

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, the societal changes in the last decade may even have further amplified late sleep in adolescents, 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.

Detailed Description

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The study is a prospective cohort-study implementing a brief behavioral and sleep hygiene education with mindfulness intervention in adolescents starting a junior collage (16 years of age). All first year students are invited to participate and those interested, willing to sign a consent and have a consent from a parent/guardian will be included in the study, except if diagnosed with chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases, or diagnosed with moderate or severe obstructive sleep apnea (OSA) then will be excluded from participating in the study.

Sleep duration, sleep timing (sleep onset and conclusion to calculate sleep mid-time and social jetlag), sleep quality, sleep efficiency and wake after sleep onset will be measured with objective home sleep test for three (3) week-nights and two (2) weekend-nights. Sleepiness, insomnia symptoms, anxiety, depression and chronotype will be evaluated with subjective questionnaires before starting intervention of behavioral and sleep hygiene education and mindfulness training once weekly. After the 8-week intervention participants sleep will be measured, sleepiness, insomnia, anxiety, depression symptoms will be re-evaluated with the same questionnaires and their knowledge of how sleep curtailments may affect health and quality of life will be tested.

Conditions

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Sleep Depression Anxiety Chronotype

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort-study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention arm

Group Type EXPERIMENTAL

Behavioral and Sleep Hygiene Education with Mindfulness Intervention

Intervention Type BEHAVIORAL

Education about good sleep hygiene practices and behavior advice to improve sleep based on current literature for 10-15 minutes/week followed by 50 minutes of yoga Nidra and breathing excersices

Interventions

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Behavioral and Sleep Hygiene Education with Mindfulness Intervention

Education about good sleep hygiene practices and behavior advice to improve sleep based on current literature for 10-15 minutes/week followed by 50 minutes of yoga Nidra and breathing excersices

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

First year student attending a junior collage in Northern Europe (Akureyri Iceland)

Exclusion Criteria

1. chronic atrial fibrillation or ventricular trigemini,
2. severe uncontrolled asthma or other pulmonary diseases,
3. moderate and severe obstructive sleep apnea (OSA)
Minimum Eligible Age

15 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akureyri Hospital

OTHER_GOV

Sponsor Role collaborator

Solveig Magnusdottir

OTHER_GOV

Sponsor Role lead

Responsible Party

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Solveig Magnusdottir

Chief Medical Officer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Solveig Magnusdottir, MD, MSc, MBA

Role: PRINCIPAL_INVESTIGATOR

MyCardio SleepImage

Locations

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Menntaskolinn a Akureyri

Akureyri, , Iceland

Site Status

Sjukrahusid a Akureyri

Akureyri, , Iceland

Site Status

Countries

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Iceland

Other Identifiers

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VSN-23-086

Identifier Type: -

Identifier Source: org_study_id

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