SleepNCT06028997
Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents
A study testing Behavioral and Sleep Hygiene Education with Mindfulness Intervention in people with Sleep and Depression, run by Solveig Magnusdottir at 2 sites in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Depression, Anxiety
- What is being tested?
- Behavioral and Sleep Hygiene Education with Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIceland
- Study dates
- 28 Aug 2023to 19 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First year student attending a junior collage in Northern Europe (Akureyri Iceland)
Who cannot join
- chronic atrial fibrillation or ventricular trigemini,
- severe uncontrolled asthma or other pulmonary diseases,
- moderate and severe obstructive sleep apnea (OSA)
Trial locations and contacts
2 sites in 1 country.
Iceland2 sites
Menntaskolinn a Akureyri
Akureyri, 600
Sjukrahusid a Akureyri
Akureyri, 600
About this study
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
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.
Read the 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.
- Conditions
- Sleep, Depression, Anxiety, Chronotype
- Being tested
- Behavioral and Sleep Hygiene Education with Mindfulness Intervention
- Keywords
- sleep regularity, sleep duration, adolescents, behavioral therapy, sleep hygiene education, mindfulness intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral and Sleep Hygiene Education with Mindfulness InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Behavioral: Behavioral and Sleep Hygiene Education with Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronotype and relationship with sleep duration, anxiety- and depression symptoms
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)
Measured: Baseline and week 9
Chronotype and relationship with anxiety symptoms
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)
Measured: Baseline and week 9
Chronotype and relationship with depression symptoms
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
Measured: Baseline and week 9
Chronotype and relationship with depression symptoms
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
Measured: Baseline and week 9
Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention
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)
Measured: Baseline and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start28 Aug 2023
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort-study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solveig Magnusdottir
- Sponsor type
- Other government
- Collaborators
- Akureyri Hospital
- Responsible party
- Sponsor-investigator, Solveig Magnusdottir, Akureyri Hospital
- Investigators
- Solveig Magnusdottir, MD, MSc, MBA, Principal investigator, MyCardio SleepImage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028997
- Sponsor's protocol ID
- VSN-23-086
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06028997
- Acronym / sponsor ID
- VSN-23-086
- Conditions
- Sleep, Depression, Anxiety, Chronotype
- Keywords
- sleep regularity, sleep duration, adolescents, behavioral therapy, sleep hygiene education, mindfulness intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Solveig MagnusdottirOther government
- Collaborators
- Akureyri Hospital
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort-study
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Behavioral and Sleep Hygiene Education with Mindfulness Intervention |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- First year student attending a junior collage in Northern Europe (Akureyri Iceland)
Key exclusion criteria (3 listed)
- chronic atrial fibrillation or ventricular trigemini,
- severe uncontrolled asthma or other pulmonary diseases,
- moderate and severe obstructive sleep apnea (OSA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral and Sleep Hygiene Education with Mindfulness InterventionEducation 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 | Behavioural | Intervention arm |
Primary outcome
Chronotype and relationship with sleep duration, anxiety- and depression symptoms
Time frame: 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)
Chronotype and relationship with anxiety symptoms
Time frame: 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)
Chronotype and relationship with depression symptoms
Time frame: 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
Chronotype and relationship with depression symptoms
Time frame: 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
Change in sleep regularity and social jetlag from baseline to follow up after 8-weeks of intervention
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solveig Magnusdottir, MD, MSc, MBA principal investigator
MyCardio SleepImage
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral and Sleep Hygiene Education with Mindfulness Intervention in people with Sleep and Depression, run by Solveig Magnusdottir at 2 sites in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronotype and relationship with sleep duration, anxiety- and depression symptoms (time frame: Baseline and week 9). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.