SleepNCT05748496
Study to Evaluate Efficacy of Brief Behavioral and Sleep Hygiene Education With Mindfulness Intervention on Sleep Quality
A study testing Brief behavioral sleep therapy, sleep hygiene education and mindfulness training in people with Sleep, run by Solveig Magnusdottir at 1 site 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 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Brief behavioral sleep therapy, sleep hygiene education and mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIceland
- Study dates
- 20 Feb 2023to 28 Apr 2023
- 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students interested to participate and able to sign enlightened consent
Who cannot join
- Atrial fibrillation or ventricular trigeminy Severe and uncontrolled asthma or severe pulmonary disease Moderate and severe obstructive sleep apnoea (OSA)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Sleep
- Being tested
- Brief behavioral sleep therapy, sleep hygiene education and mindfulness training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief behavioral sleep therapy, sleep hygiene education and mindfulness trainingBehavioural
Brief behavioral sleep therapy, sleep hygiene education and mindfulness training using breathing exercises and Yoga Nidra
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Brief behavioral sleep therapy, sleep hygiene education and mindfulness training |
| Controle | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate if changes will be observed in sleep quality measured with sleep quality index (SQI)
Intervention with brief behavioral and sleep hygiene education and mindfulness training with breathing exercises and Yoga Nidra
Measured: 4-week intervention
To evaluate if changes will be observed in sleep timing and duration (hours, minutes)
Intervention with brief behavioral and sleep hygiene education and mindfulness training with breathing exercises and Yoga Nidra
Measured: 4-week intervention
Secondary outcomes (1)
To evaluate if changes will be observed in anxiety evaluated using the General Anxiety Disorder-7 scale (score 0-21)
Intervention with brief behavioral and sleep hygiene education and mindfulness training with breathing exercises and Yoga Nidra
Measured: 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start20 Feb 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solveig Magnusdottir
- Sponsor type
- Other government
- Collaborators
- MyCardioLLC
- Responsible party
- Sponsor-investigator, Solveig Magnusdottir, Akureyri Hospital
- Investigators
- Solveig Magnusdottir, MD, Principal investigator, MyCardioLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748496
- Sponsor's protocol ID
- VSN-22-174
- Status last verified
- Apr 2023
- First submitted
- 20 Feb 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05748496
- Acronym / sponsor ID
- VSN-22-174
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Solveig MagnusdottirOther government
- Collaborators
- MyCardioLLC
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 28 Feb 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/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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief behavioral sleep therapy, sleep hygiene education and mindfulness training |
| Controle | No intervention | – |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students interested to participate and able to sign enlightened consent
Key exclusion criteria (1 listed)
- Atrial fibrillation or ventricular trigeminy Severe and uncontrolled asthma or severe pulmonary disease Moderate and severe obstructive sleep apnoea (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 |
|---|---|---|
| Brief behavioral sleep therapy, sleep hygiene education and mindfulness trainingBrief behavioral sleep therapy, sleep hygiene education and mindfulness training using breathing exercises and Yoga Nidra | Behavioural | Intervention |
Primary outcome
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
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
1 secondary outcome
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
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 3 May 2023.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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 principal investigator
MyCardioLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief behavioral sleep therapy, sleep hygiene education and mindfulness training in people with Sleep, run by Solveig Magnusdottir at 1 site 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 1 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To evaluate if changes will be observed in sleep quality measured with sleep quality index (SQI) (time frame: 4-week intervention). The study lists 2 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 3 May 2023.