Clinical trial NCT06028997: Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents
Official title: Implementation of Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents; is There a Relationship With Anxiety, Depression or Chronotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Depression
Anxiety
Chronotype
Keywords: sleep regularity
sleep duration
adolescents
behavioral therapy
sleep hygiene education
mindfulness intervention
Lead sponsor: Akureyri Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Akureyri Hospital
First posted: 2023-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort-study
Primary purpose: BASIC_SCIENCE

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- 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Chronotype and relationship with sleep duration, anxiety- and depression symptoms
timeFrame: Baseline and week 9
measure: Chronotype and relationship with anxiety symptoms
timeFrame: Baseline and week 9
measure: Chronotype and relationship with depression symptoms
timeFrame: Baseline and week 9
measure: Chronotype and relationship with depression symptoms
timeFrame: Baseline and week 9
measure: Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention
timeFrame: Baseline and week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Akureyri
country: Iceland
facility: Menntaskolinn a Akureyri
city: Akureyri
country: Iceland
facility: Sjukrahusid a Akureyri
Study officials:
affiliation: MyCardio SleepImage
name: Solveig Magnusdottir, MD, MSc, MBA
role: PRINCIPAL_INVESTIGATOR
References: