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

Sponsor
Solveig Magnusdottir (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06028997
Collaborator
Menntaskolin a Akureyri (Other)
100
2
1
4.1
50
12.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral and Sleep Hygiene Education with Mindfulness Intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective cohort-studyProspective cohort-study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Aug 28, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

Behavioral: 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

Outcome Measures

Primary Outcome Measures

  1. Chronotype and relationship with sleep duration, anxiety- and depression symptoms [Baseline and week 9]

    Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if the different chronotype-groups differ in sleep duration (evaluated in hours and minutes)

  2. Chronotype and relationship with anxiety symptoms [Baseline and week 9]

    Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in anxiety symptoms when evaluated with the general anxiety disorder scale-7 (GAD-7), a seven item validated questionnaire designed to screen for and access severity of anxiety (based on scores from 0-21)

  3. Chronotype and relationship with depression symptoms [Baseline and week 9]

    Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the patient health questionnaire (PHQ-9), a nine-item validated questionnaire (scores from 0-27), with higher scores indicating more symptoms

  4. Chronotype and relationship with depression symptoms [Baseline and week 9]

    Chronotype evaluated with validated sleep questionnaire the Morningness-Eveningness Questionnaire (MEQ), a nineteen-item questionnaire to assess the preferred timing of sleep and activity (outcome presented on scale of 31-86 points) to identify early-, intermediate- and evening chronotypes and evaluate if they differ in depression symptoms when evaluated with the Becks depression inventory (BDI-II) a ten-item questionnaires to screen for and access severity of depression (scores from 0-63) symptoms, with higher scores indicating more symptoms

  5. Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention [Baseline and week 9]

    Sleep duration, sleep onset and sleep conclusions (all measured in hours and minutes) to calculate sleep midpoint on school- and free days, to calculate social jetlag (in hours and minutes)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Menntaskolinn a Akureyri Akureyri Iceland 600
2 Sjukrahusid a Akureyri Akureyri Iceland 600

Sponsors and Collaborators

  • Solveig Magnusdottir
  • Menntaskolin a Akureyri

Investigators

  • Principal Investigator: Solveig Magnusdottir, MD, MSc, MBA, MyCardio SleepImage

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Solveig Magnusdottir, Chief Medical Officer, Akureyri Hospital
ClinicalTrials.gov Identifier:
NCT06028997
Other Study ID Numbers:
  • VSN-23-086
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Solveig Magnusdottir, Chief Medical Officer, Akureyri Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023