Intervention EffectivenessNCT07371637
Charge Your Brainzzz: Evaluation of the Effectiveness and Implementation of an Integrated Approach to Improve Dutch Teenagers' Sleep Health
A study testing Charge Your Brainzzz in people with Intervention Effectiveness and Implementation Research, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
Poor sleep among teenagers is a major public health issue. Studies show that in the Netherlands, nearly half of adolescents don't wake up feeling rested, one in five feel sleepy during the day, one in four regularly wake up at night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intervention Effectiveness, Implementation Research
- What is being tested?
- Charge Your Brainzzz
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Dutch regular secondary schools that include at least one vocational track (VMBO)
- First-year students enrolled in the VMBO tracks of participating schools
- Teachers, school health professionals, school care coordinators, school management, and the regional municipal health service's (GGD) Healthy School advisors who work with at least one of the participating schools
Who cannot join
- non-regular Dutch secondary schools / special education
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Charge Your Brainzzz: Evaluation of an Integrated Approach to Improve Teenagers' Sleep Health
Poor sleep among teenagers is a major public health issue. Studies show that in the Netherlands, nearly half of adolescents don't wake up feeling rested, one in five feel sleepy during the day, one in four regularly wake up at night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended 8-10 hours per night. Over the past decade, teenagers' average sleep time has dropped by about 40 minutes.
Good sleep health means having a regular sleep rhythm with about 8-10 hours of quality sleep each night. This is crucial, because poor sleep in teenagers can lead to problems with thinking, learning, concentration, and school performance. In the long run, it also increases the risk of serious health issues such as anxiety, depression, obesity, diabetes, cardiovascular disease, and even dementia.
Read more
Because of these risks, schools, municipalities, and public health services are calling for effective ways to prevent sleep problems among teenagers. The Dutch "Healthy School" program has recently added sleep as a core theme, but proven, practical interventions are still lacking.
To address this gap, the Charge Your Brainzzz (CYB) program was developed. CYB is a comprehensive approach designed to help secondary school students improve their sleep and mental well-being. It is based on the Healthy School framework and includes all four pillars: education, environment, policy, and early detection.
In 2024, a pilot study tested the CYB approach for its initial effectiveness and suitability. Early results showed positive changes in sleep outcomes and strong appreciation from both schools and students. However, before CYB can be rolled out nationwide, more evidence is needed on its effectiveness, fit with schools, and how it can be sustained over time.
That's why this project will conduct a large-scale evaluation of both the impact of CYB and the processes needed for successful implementation. Alongside the effectiveness study, a practical roadmap will be co-created with schools, Healthy School Advisors, and local coordinators to ensure that CYB can be optimally implemented, sustained, and scaled up across schools, municipalities, and public health services across the Dutch public health landscape.
Read the detailed description
Poor sleep health among adolescents is a major public health problem. In the Netherlands, nearly half of adolescents report not waking up feeling rested, one in five say they feel sleepy during the day, one in four regularly do not sleep through the night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended 8-10 hours per night. Over the past ten years, adolescents' average sleep duration has decreased by about 40 minutes.
Sleep health refers to maintaining a regular sleep rhythm of approximately 8-10 hours of good-quality sleep per night. Sleep health is extremely important, because when teenagers sleep poorly, they may experience declines in cognition, learning ability, concentration, and school performance. Moreover, poor sleep in adolescence increases the risk of long-term health problems such as anxiety and depression, obesity, diabetes, cardiovascular disease, and dementia.
From both research and the practical experience of schools, municipalities, and public health services, there is a strong demand for effective interventions to address these problems through prevention among teenagers. The Dutch "Healthy School" program (Gezonde School) shares this sense of urgency and has recently added sleep as a core theme. However, proven effective interventions for practice are still lacking.
To fill this gap, the integrated Charge Your Brainzzz (CYB) approach was recently developed to support secondary school students in improving their sleep and mental well-being. The approach is based on the Healthy School framework, with well-substantiated applications of all four Healthy School pillars: Education, Environment, Policy, and Early Detection.
In 2024, a pilot study was conducted to evaluate the initial effectiveness and suitability of the CYB approach (Pilot Study results in draft, 2025). Preliminary results from this pilot evaluation showed positive changes in sleep outcomes and strong appreciation from both schools and adolescents. However, before schools, municipalities, and public health services can implement CYB nationwide within the Healthy School framework, it is important to establish clarity about the program's effectiveness, appropriateness, sustainability processes, and, above all, its efficacy. Therefore, a sufficiently large, controlled evaluation study is needed to assess both effectiveness in practice and the processes of implementation and sustainability.
This project will therefore evaluate both the effectiveness as well as the implementation and sustainability processes of the CYB approach. In parallel, a step-by-step plan will be co-created with schools, Healthy School Advisors, and local JOGG coordinators to enable them to implement, sustain, and scale up the CYB approach across schools, municipalities, and public health services.
- Being tested
- Charge Your Brainzzz
- Keywords
- sleep, adolescent, healthy school, charge your brainzzz, evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charge Your BrainzzzBehavioural
Charge Your Brainzzz is a comprehensive health promoting school approach intervention, designed to help Dutch secondary school students improve their sleep and sleep hygiene habits. It is based on the Health Promoting School framework and includes all its four pillars, i.e. (1) an education component, (2) a set of components that focus on involving students' (home) environment, a set of school policy changes related to school start times, schools' digital communication activities and schools' stimulation of daytime physical activity of students, and, lastly, (4) a set of tools that school health professionals can use to facilitate the early detection of potential (future) student sleep problems.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Charge Your Brainzzz |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleep health
Subjective sleep health will be assessed using a concise questionnaire that comprehensively covers the submeasures (1) sleep duration, (2) sleep quality, (3) sleep efficiency, (4) bedtime routines/sleep hygiene, (5) sleep timing, and (6) daytime sleepiness [1,2]. In addition to sleep health, the most relevant behavioral determinants will be measured at each assessment point, alongside the direct targets of the CYB program. These include, for example, the presence of household rules regarding bedtimes and wake-up times, as well as adolescents' sleep hygiene practices, with particular attention to evening screen use and the presence of a mobile phone in the bedroom at night.
Time frame of data collection: prior to implementation of the program (T0), within two weeks after completion of the educational component, (T1), and at six-month follow-up after T1 (T2).
- Buysse (2014). https://doi.org/10.5665/sleep.3298
- Meltzer (2021). https://doi.org/10.1016/j.smrv.2021.101425
Measured: From the start of the intervention until 6 months after its completion
Objective sleep duration
A random selection of approximately two classes per participating school will wear GeneActiv sleep monitors during the three measurement periods (T0, T1, T2) to objectively assess sleep duration and sleep quality. These sleep monitors will be worn continuously on the wrist for a period of five weekdays. These devices measure the activity pattern, temperature, and ambient light surrounding the student wearing them.
Measured: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.
Objective sleep quality
A random selection of approximately two classes per participating school will wear GeneActiv sleep monitors during the three measurement periods (T0, T1, T2) to objectively assess sleep duration and sleep quality. These sleep monitors will be worn continuously on the wrist for a period of five weekdays. These devices measure the activity pattern, temperature, and ambient light surrounding the student wearing them. Additionally, during these days, students will complete a sleep diary each morning (approximately 5 minutes).
Measured: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.
Subjective Sleep Duration
All participating students will complete a sleep diary each morning (approximately 5 minutes) in which they report their sleep duration.
Measured: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.
Secondary outcomes (9)
Students' knowledge on healthy sleep
An assessment of students' knowledge on healthy sleep, based on the content of what's being taught via the CYB intervention program
Measured: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' attitude towards sleep health
An assessment of students' attitude towards healthy sleep and their awareness of its importance to their health, wellbeing and ability to learn, based on the content of what's being taught via the CYB intervention program
Measured: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' self-efficacy in relation to their sleep health
An assessment of students' self-efficacy/skills in relation to regulating their healthy sleep habits, based on the content of what's being taught via the CYB intervention program
Measured: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' subjective norms in relation to sleep health of their peers and parents
An assessment of the subjective norm that students experience in their social environment in relation to healthy sleep habits.
Measured: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' behavioral intention to sleep healthier
An assessment of whether students have the intention to exhibit healthier sleep habitss as a consequence of their school participating in the CYB intervention program
Measured: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' sleep hygiene practices
An assessment of students' pre-sleep habits, or sleep hygiene practices, based on the content of what's being taught via the CYB intervention program
Measured: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Appreciation and acceptance of the intervention
In the first school year following the start of the implementation of the program (T1), and again six months later (T2), semi-structured interviews will be conducted with implementers of the CYB approach, i.e., the various school professionals involved, in order to monitor and evaluate the implementation within the school setting
Measured: In the first school year following the start of the implementation of the program (T1), and again six months later (T2)
Facilitators and barriers in relation to the intervention's adoption, implementation and sustainment
An assessment of the facilitators and barriers in relation to the adoption, implementation and sustainment processes of the CYB program
Measured: In the first school year following the start of the implementation of the program (T1), and again six months later (T2)
Ripple effects mapping
The broader impact of the CYB program will be evaluated using the innovative systems-based evaluation method Ripple Effects Mapping (REM). Through this approach, we will work with implementers of the CYB program to capture, in real time, the overall impact of CYB. Ripple Effects Mapping provides an overview of both the direct and indirect effects of the various program components. These may occur within schools, within municipalities, at the level of the CYB program owner, or in other ways in which the intervention may have had unforeseen impact.
REM sessions will commence once the CYB program has been expanded with activities beyond the school setting and will subsequently take place approximately every four months. During these sessions, time will be devoted to reviewing the actions and changes that have occurred in the past four months (retrospective analysis) as well as those that are expected or planned for the coming four months.
Measured: Every 4 months after the start of the intervention's implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervention EffectivenessStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive the CYB intervention, while the other group will serve as a control group getting regular Dutch secondary school education
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maartje van Stralen, VU University of Amsterdam
- Investigators
- Maartje M van Stralen, PhD, Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371637
- Sponsor's protocol ID
- CYB3
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 28 Jan 2026
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Charge Your Brainzzz: Evaluation of an Integrated Approach to Improve Teenagers' Sleep Health
- ClinicalTrials.gov ID
- NCT07371637
- Acronym / sponsor ID
- CYB3
- Keywords
- sleep, adolescent, healthy school, charge your brainzzz, evaluation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 28 Jan 2026 (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.
Poor sleep among teenagers is a major public health issue. Studies show that in the Netherlands, nearly half of adolescents don't wake up feeling rested, one in five feel sleepy during the day, one in four regularly wake up at night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended 8-10 hours per night. Over the past decade, teenagers' average sleep time has dropped by about 40 minutes.
Good sleep health means having a regular sleep rhythm with about 8-10 hours of quality sleep each night. This is crucial, because poor sleep in teenagers can lead to problems with thinking, learning, concentration, and school performance. In the long run, it also increases the risk of serious health issues such as anxiety, depression, obesity, diabetes, cardiovascular disease, and even dementia.
Because of these risks, schools, municipalities, and public health services are calling for effective ways to prevent sleep problems among teenagers. The Dutch "Healthy School" program has recently added sleep as a core theme, but proven, practical interventions are still lacking.
To address this gap, the Charge Your Brainzzz (CYB) program was developed. CYB is a comprehensive approach designed to help secondary school students improve their sleep and mental well-being. It is based on the Healthy School framework and includes all four pillars: education, environment, policy, and early detection.
In 2024, a pilot study tested the CYB approach for its initial effectiveness and suitability. Early results showed positive changes in sleep outcomes and strong appreciation from both schools and students. However, before CYB can be rolled out nationwide, more evidence is needed on its effectiveness, fit with schools, and how it can be sustained over time.
That's why this project will conduct a large-scale evaluation of both the impact of CYB and the processes needed for successful implementation. Alongside the effectiveness study, a practical roadmap will be co-created with schools, Healthy School Advisors, and local coordinators to ensure that CYB can be optimally implemented, sustained, and scaled up across schools, municipalities, and public health services across the Dutch public health landscape.
Detailed description
Poor sleep health among adolescents is a major public health problem. In the Netherlands, nearly half of adolescents report not waking up feeling rested, one in five say they feel sleepy during the day, one in four regularly do not sleep through the night, 65% rate their own sleep quality as poor, and 43% sleep less than the recommended 8-10 hours per night. Over the past ten years, adolescents' average sleep duration has decreased by about 40 minutes.
Sleep health refers to maintaining a regular sleep rhythm of approximately 8-10 hours of good-quality sleep per night. Sleep health is extremely important, because when teenagers sleep poorly, they may experience declines in cognition, learning ability, concentration, and school performance. Moreover, poor sleep in adolescence increases the risk of long-term health problems such as anxiety and depression, obesity, diabetes, cardiovascular disease, and dementia.
From both research and the practical experience of schools, municipalities, and public health services, there is a strong demand for effective interventions to address these problems through prevention among teenagers. The Dutch "Healthy School" program (Gezonde School) shares this sense of urgency and has recently added sleep as a core theme. However, proven effective interventions for practice are still lacking.
To fill this gap, the integrated Charge Your Brainzzz (CYB) approach was recently developed to support secondary school students in improving their sleep and mental well-being. The approach is based on the Healthy School framework, with well-substantiated applications of all four Healthy School pillars: Education, Environment, Policy, and Early Detection.
In 2024, a pilot study was conducted to evaluate the initial effectiveness and suitability of the CYB approach (Pilot Study results in draft, 2025). Preliminary results from this pilot evaluation showed positive changes in sleep outcomes and strong appreciation from both schools and adolescents. However, before schools, municipalities, and public health services can implement CYB nationwide within the Healthy School framework, it is important to establish clarity about the program's effectiveness, appropriateness, sustainability processes, and, above all, its efficacy. Therefore, a sufficiently large, controlled evaluation study is needed to assess both effectiveness in practice and the processes of implementation and sustainability.
This project will therefore evaluate both the effectiveness as well as the implementation and sustainability processes of the CYB approach. In parallel, a step-by-step plan will be co-created with schools, Healthy School Advisors, and local JOGG coordinators to enable them to implement, sustain, and scale up the CYB approach across schools, municipalities, and public health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive the CYB intervention, while the other group will serve as a control group getting regular Dutch secondary school education
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Charge Your Brainzzz |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Dutch regular secondary schools that include at least one vocational track (VMBO)
- First-year students enrolled in the VMBO tracks of participating schools
- Teachers, school health professionals, school care coordinators, school management, and the regional municipal health service's (GGD) Healthy School advisors who work with at least one of the participating schools
Key exclusion criteria (1 listed)
- non-regular Dutch secondary schools / special education
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 |
|---|---|---|
| Charge Your BrainzzzCharge Your Brainzzz is a comprehensive health promoting school approach intervention, designed to help Dutch secondary school students improve their sleep and sleep hygiene habits. It is based on the Health Promoting School framework and includes all its four pillars, i.e. (1) an education component, (2) a set of components that focus on involving students' (home) environment, a set of school policy changes related to school start times, schools' digital communication activities and schools' stimulation of daytime physical activity of students, and, lastly, (4) a set of tools that school health professionals can use to facilitate the early detection of potential (future) student sleep problems. | Behavioural | Intervention group |
Primary outcome
Subjective sleep health
Time frame: From the start of the intervention until 6 months after its completion
Subjective sleep health will be assessed using a concise questionnaire that comprehensively covers the submeasures (1) sleep duration, (2) sleep quality, (3) sleep efficiency, (4) bedtime routines/sleep hygiene, (5) sleep timing, and (6) daytime sleepiness [1,2]. In addition to sleep health, the most relevant behavioral determinants will be measured at each assessment point, alongside the direct targets of the CYB program. These include, for example, the presence of household rules regarding bedtimes and wake-up times, as well as adolescents' sleep hygiene practices, with particular attention to evening screen use and the presence of a mobile phone in the bedroom at night. Time frame of data collection: prior to implementation of the program (T0), within two weeks after completion of the educational component, (T1), and at six-month follow-up after T1 (T2). 1. Buysse (2014). https://doi.org/10.5665/sleep.3298 2. Meltzer (2021). https://doi.org/10.1016/j.smrv.2021.101425
Objective sleep duration
Time frame: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.
A random selection of approximately two classes per participating school will wear GeneActiv sleep monitors during the three measurement periods (T0, T1, T2) to objectively assess sleep duration and sleep quality. These sleep monitors will be worn continuously on the wrist for a period of five weekdays. These devices measure the activity pattern, temperature, and ambient light surrounding the student wearing them.
Objective sleep quality
Time frame: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.
A random selection of approximately two classes per participating school will wear GeneActiv sleep monitors during the three measurement periods (T0, T1, T2) to objectively assess sleep duration and sleep quality. These sleep monitors will be worn continuously on the wrist for a period of five weekdays. These devices measure the activity pattern, temperature, and ambient light surrounding the student wearing them. Additionally, during these days, students will complete a sleep diary each morning (approximately 5 minutes).
Subjective Sleep Duration
Time frame: During five weekdays directly prior to the start of the intervention's implementation, within two weeks after its completion, and six months thereafter.
All participating students will complete a sleep diary each morning (approximately 5 minutes) in which they report their sleep duration.
9 secondary outcomes
Students' knowledge on healthy sleep
Time frame: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' attitude towards sleep health
Time frame: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' self-efficacy in relation to their sleep health
Time frame: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' subjective norms in relation to sleep health of their peers and parents
Time frame: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' behavioral intention to sleep healthier
Time frame: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Students' sleep hygiene practices
Time frame: Prior to intervention implementation (T0), within two weeks after intervention completion (T1), and six months after T1.
Appreciation and acceptance of the intervention
Time frame: In the first school year following the start of the implementation of the program (T1), and again six months later (T2)
Facilitators and barriers in relation to the intervention's adoption, implementation and sustainment
Time frame: In the first school year following the start of the implementation of the program (T1), and again six months later (T2)
Ripple effects mapping
Time frame: Every 4 months after the start of the intervention's implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- intervention descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Maartje M van Stralen, PhD principal investigator
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charge Your Brainzzz in people with Intervention Effectiveness and Implementation Research, run by VU University of Amsterdam at 1 site in Netherlands.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subjective sleep health (time frame: From the start of the intervention until 6 months after its completion). The study lists 4 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 28 Jan 2026.