Sleep HygieneHealth CASCADENCT05838339
Are You Daydreaming?
A study testing Healthy Sleep Intervention in people with Sleep Hygiene and Sleep, run by University Ghent at 1 site in Belgium.
Trial summary
Health CASCADE (Marie Skłodowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Hygiene, Sleep, Poor Quality Sleep
- What is being tested?
- Healthy Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Oct 2022to 24 Nov 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students must be aged between 11 and 13 years. Parents must have at least one child in the 6th or 7th Grade of the participating school.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are You Daydreaming? Co-creation to Promote Healthy Sleep in Adolescents in a School Context: a Health CASCADE Protocol
Health CASCADE (Marie Skłodowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. The current study, which focuses on co-creation in the school context is part of this overarching European project.
Healthy sleep is important for adolescents' mental and physical health and cognitive functioning. However, sleep difficulties are among the top three health complaints in European adolescents. This indicates a need for successful interventions.
Read more
Co-creation is a promising approach to design tailored interventions. By actively involving all relevant stakeholders, co-creation has been shown to increase self-efficacy, self-consciousness, empowerment, and feelings of ownership. However, co-created interventions are localized and therefore less generalizable to a broader population. Moreover, the process is very time- and cost- consuming. To make co-creation more feasible, research should focus on the upscaling of existing interventions. The investigators propose that the co-creation process is still absolutely vital for intervention success but that it can be shortened.
The investigators aim to scale up an existing intervention to promote healthy sleep. This existing intervention was developed using co-creation together with the target group (adolescents aged 13 to 15) and parents, and implemented with support of teachers and fellow students. To investigate whether the shorter co-creation process is needed in order to scale up the intervention to another setting and context, the investigators will use a three-arm cluster controlled trial. This will include one co-creation intervention school, one standard implementation school (this school receives the existing intervention without a shortened co-creation process), and one control school. The co-creation process will be structured by using the Intervention Mapping Protocol to ensure an evidence-based framework. The effect of the intervention will be evaluated using actigraphy and questionnaires, while the process will be evaluated using questionnaires, interviews, and focus groups.
Read the detailed description
The aim of this study is to scale up an existing sleep intervention (co-created with adolescents and parents, and implemented with the support of teachers and fellow students) in Flanders to improve sleeping behavior. Scaling up an intervention is defined as transferring an intervention to another context, setting, and group. As co-created interventions are localized by nature, the researchers will investigate whether this existing intervention can be scaled up to a new context, setting, and group while the aim of the intervention remains the same, i.e., improving healthy sleeping behavior in adolescents. To test this, a co-creation school, standard implementation school, and control school will be recruited. Below, the investigators will describe what will be expected from each condition.
Co-creation school: Scaling up the existing sleep intervention to a new context, setting, and group will proceed in the co-creation school. The existing intervention will be adapted to the culture of this school, based on students', school staff's, and parents' perspective on the health problem (unhealthy sleeping behavior in adolescents) and thoughts on the components of the existing intervention. To adapt the existing sleep intervention, action groups will be composed. Every action group contains a maximum of 10 individuals.
- Action group adolescents: This action group consists of a maximum of 10 students from the 6th and 7th grade (1st grade secondary school, Belgian school system). The participants will be involved in the adaptation of existing intervention components. Furthermore, participants will implement the adapted intervention at school.
- Action group school staff: This action group consists of a maximum of 10 individuals working at the co-creation school. Participants will be involved in designing an implementation plan for the intervention. Moreover, participants will be asked to check the adapted components for feasibility.
- Action group parents: This action group consists of a maximum of 10 parents who have at least one child in the 6th or 7th grade of the co-creation school. Parents will be involved in the adaptation of the parental intervention components of the existing intervention.
- Co-facilitators: Students of the 12th grade (year 6 secondary school, Belgian school system) will be involved as co-facilitators. This means that the students of the 12th grade will facilitate the co-creation sessions designed for the students of the 6th and 7th grade together with the researchers.
Standard implementation school: To test the added value of the shortened co-creation process and to show that this process is needed to build ownership and empowerment, the existing sleep intervention will be implemented without the shortened co-creation process. The standard implementation school will be provided with a manual and a training about the implementation of the intervention.
Control school: To test the overall effect of the intervention a control group is needed. None of the interventions will be implemented at the control school and therefore the school staff do not have to take part in the measurements.
In total, the intervention in both the co-creation school and the standard implementation school will take 9 weeks.
Effect evaluation: To test the effect of the intervention, students (n = 378, based on a power analysis performed in R) will be invited to take part in three measurements (baseline, posttest (after the intervention), and follow-up (sixth months after the end of the intervention)) in all three arms. For members of the action group, a fourth measure will be administered (in-between baseline and posttest) to investigate whether the co-creation process itself can lead to changes in specific variables (see measures section). In order to compare the co-creation process to a standard implementation training, this fourth measurement will also be assessed among individuals involved in the implementation in the standard implementation school. To objectively measure sleep, participants will be asked to wear a GENEActiv device for 7 consecutive days at each of the three measurement points. Furthermore, participants will be invited to complete a questionnaire. This questionnaire will consist of questions about sleep duration, sleep quality, daytime sleepiness, sleep hygiene, determinants of sleeping behavior (knowledge, attitude, self-efficacy specifically related to sleeping behavior, social influence and social support, barriers), mental wellbeing, and feelings of empowerment and ownership. Furthermore, SES, puberty, and BMI will be assessed as important covariates. For students who are part of the action group (in the co-creation school) the questionnaire will also contain questions about general self-efficacy, and self-esteem. Moreover, students who are part of the action group will be invited to complete the whole questionnaire at one additional time point, namely after the shortened co-creation process. This measurement will enable us to investigate whether students in the action group experience more general self-efficacy and feelings of self-esteem as a result of participation in the co-creation process. Parents (ideally n = 378, one parent of each participating student) will be invited to complete questionnaires at the same measurement points as the students in all three arms. Parents' questionnaire will contain questions about knowledge and attitude about sleep, whether parents impose bedtime rules on children or have other supportive strategies, and questions regarding self-efficacy in engaging in these supportive strategies. Completion of questionnaires for students will take about one lesson (40-50 minutes). For parents, completion will take about 15 minutes.
Process evaluation: To evaluate the co-creation process as well as the implementation of the intervention, the investigators will use questionnaires, interviews, and focus groups. Students and parents from the action group will be asked to provide a short evaluation after every co-creation session. More extensive evaluations (focus group) will take place half-way during the development of the intervention, once the adaptation of the intervention is finished, and after the implementation of the intervention is done. Fellow students and parents, who are not part of the action group will be asked to evaluate the implementation of the intervention as well, using a short questionnaire. Students will also be invited to take part in focus groups. School staff (co-creation arm and standard implementation arm) will be invited to complete a questionnaire measuring motivation, empowerment, barriers for implementation, and general knowledge about sleep at three time points (baseline, pre-implementation, and after the intervention). Completion of questionnaires for school staff will take about 30 minutes. Moreover, school staff will be invited to take part in focus groups as well. These will take place at the same time points as for the students. Focus groups will take around 50 minutes (one lesson).
- Conditions
- Sleep Hygiene, Sleep, Poor Quality Sleep
- Being tested
- Healthy Sleep Intervention
- Keywords
- Adolescence, Sleeping behavior, Co-creation, School-based intervention, School staff, Parents, Mental Health, Sleep, Motivation, Ownership, Health Promotion
- Medical subject headings
- Sleep Hygiene, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Sleep InterventionBehavioural
The existing intervention consists of the following components: Posters, Instagram, kick-off event, flyer for parents, parents-teacher conference, class discussions, app, classes on sleep (and relaxation), blue lights installations, alarm clocks and t-shirts, T-days without phone in the bedroom (Tuesdays and Thursdays), class competition.
| Study group | Role | What they receive |
|---|---|---|
| Co-creation School | Experimental | An existing healthy sleep intervention will be scaled up using a shortened co-creation process. An effect- and process evaluation will be performed. Receives: Behavioral: Healthy Sleep Intervention |
| Standard Implementation School | Active comparator | The existing healthy sleep intervention will be implemented without using a co-creation approach. An effect- and process evaluation will be performed. Receives: Behavioral: Healthy Sleep Intervention |
| Control School | No intervention | No intervention will be implemented. An effect evaluation will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quantity school days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Measured: Baseline
Sleep quantity free days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Measured: Baseline
Sleep quantity school days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Sleep quantity free days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Sleep quantity school days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Measured: Immediately after the intervention
Sleep quantity free days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Measured: Immediately after the intervention
Sleep quantity school days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Measured: 6 months after the intervention
Sleep quantity free days
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Measured: 6 months after the intervention
Objective sleep quantity school days
Will be assessed objectively using actigraphy (GENEActivs)
Measured: Baseline
Objective sleep quantity free days
Will be assessed objectively using actigraphy (GENEActivs)
Measured: Baseline
Objective sleep quantity school days
Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Objective sleep quantity free days
Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Objective sleep quantity school days
Will be assessed objectively using actigraphy (GENEActivs)
Measured: Immediately after the intervention
Objective sleep quantity free days
Will be assessed objectively using actigraphy (GENEActivs)
Measured: Immediately after the intervention
Objective sleep quantity school days
Will be assessed objectively using actigraphy (GENEActivs)
Measured: 6 months after the intervention
Objective sleep quantity free days
Will be assessed objectively using actigraphy (GENEActivs)
Measured: 6 months after the intervention
Sleep quality - general
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS)
Measured: Baseline
Sleep quality - daytime sleepiness
Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS)
Measured: Baseline
Sleep quality school days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Measured: Baseline
Sleep quality free days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Measured: Baseline
Objective sleep quality
Will be assessed objectively using actigraphy (GENEActivs)
Measured: Baseline
Sleep quality - general
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Sleep quality - daytime sleepiness
Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Sleep quality school days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ. The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Sleep quality free days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ. The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Objective sleep quality
Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Sleep quality - general
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS).
Measured: Immediately after the intervention
Sleep quality - daytime sleepiness
Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS)
Measured: Immediately after the intervention
Sleep quality school days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Measured: Immediately after the intervention
Sleep quality free days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Measured: Immediately after the intervention
Objective sleep quality
Will be assessed objectively using actigraphy (GENEActivs)
Measured: Immediately after the intervention
Sleep quality - general
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS)
Measured: 6 months after the intervention
Sleep quality - daytime sleepiness
Will be assessed using the Pediatric Daytime Sleepiness Scale
Measured: 6 months after the intervention
Sleep quality school days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Measured: 6 months after the intervention
Sleep quality free days - SOL
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Measured: 6 months after the intervention
Objective sleep quality
Will be assessed objectively using actigraphy (GENEActivs)
Measured: 6 months after the intervention
Secondary outcomes (29)
Determinants of sleeping behavior
A questionnaire to assess psychosocial determinants of adolescents' sleeping behavior was developed. This questionnaire assesses knowledge, attitude, self-efficacy, social influence, barriers, and facilitators for healthy sleeping behavior, as well as sleep hygiene (nutrition, physical activity).
Measured: Baseline
Determinants of sleeping behavior
A questionnaire to assess psychosocial determinants of adolescents' sleeping behavior was developed. This questionnaire assesses knowledge, attitude, self-efficacy, social influence, barriers, and facilitators for healthy sleeping behavior, as well as sleep hygiene (nutrition, physical activity). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Determinants of sleeping behavior
A questionnaire to assess psychosocial determinants of adolescents' sleeping behavior was developed. This questionnaire assesses knowledge, attitude, self-efficacy, social influence, barriers, and facilitators for healthy sleeping behavior, as well as sleep hygiene (nutrition, physical activity).
Measured: Immediately after the intervention
Determinants of sleeping behavior
A questionnaire to assess psychosocial determinants of adolescents' sleeping behavior was developed. This questionnaire assesses knowledge, attitude, self-efficacy, social influence, barriers, and facilitators for healthy sleeping behavior, as well as sleep hygiene (nutrition, physical activity).
Measured: 6 months after the intervention
Mental wellbeing
Mental wellbeing will be assessed with the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS).
Measured: Baseline
Mental wellbeing
Mental wellbeing will be assessed with the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Mental wellbeing
Mental wellbeing will be assessed with the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS).
Measured: Immediately after the intervention
Mental wellbeing
Mental wellbeing will be assessed with the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS).
Measured: 6 months after the intervention
Self-efficacy
General Self-efficacy Scale (GSE) will be used to assess self-efficacy in children who are part of the action group.
Measured: Baseline
Self-efficacy
General Self-efficacy Scale (GSE) will be used to assess self-efficacy in children who are part of the action group.
Measured: Pre-intervention, after the co-creation process
Self-efficacy
General Self-efficacy Scale (GSE) will be used to assess self-efficacy in children who are part of the action group.
Measured: Immediately after the intervention
Self-efficacy
General Self-efficacy Scale (GSE) will be used to assess self-efficacy in children who are part of the action group.
Measured: 6 months after the intervention
Empowerment
Empowerment will be measured with the policy control dimension of the Social Political Control Scale for Youth (SPCS-Y) in both students and school staff as this scale focuses specifically on the school context.
Measured: Baseline
Empowerment
Empowerment will be measured with the policy control dimension of the Social Political Control Scale for Youth (SPCS-Y) in both students and school staff as this scale focuses specifically on the school context. The pre-intervention assessment will only be done for members of the action group.
Measured: Pre-intervention, after the co-creation process
Empowerment
Empowerment will be measured with the policy control dimension of the Social Political Control Scale for Youth (SPCS-Y) in both students and school staff as this scale focuses specifically on the school context.
Measured: Immediately after the intervention
Empowerment
Empowerment will be measured with the policy control dimension of the Social Political Control Scale for Youth (SPCS-Y) in both students and school staff as this scale focuses specifically on the school context.
Measured: 6 months after the intervention
General motivation
The Dutch Basic Psychological Needs Satisfaction Needs Frustration Scale (BPNSFS) will be used to measure school staff's motivation.
Measured: Baseline
General motivation
The Dutch Basic Psychological Needs Satisfaction Needs Frustration Scale (BPNSFS) will be used to measure school staff's motivation.
Measured: Pre-intervention, after the co-creation process
General motivation
The Dutch Basic Psychological Needs Satisfaction Needs Frustration Scale (BPNSFS) will be used to measure school staff's motivation.
Measured: Immediately after the intervention
Self-esteem
The Rosenberg Self-esteem Scale will be used to measure self-esteem in children who are part of the action group.
Measured: Baseline
Self-esteem
The Rosenberg Self-esteem Scale will be used to measure self-esteem in children who are part of the action group.
Measured: Pre-intervention, after the co-creation process
Self-esteem
The Rosenberg Self-esteem Scale will be used to measure self-esteem in children who are part of the action group.
Measured: Immediately after the intervention
Self-esteem
The Rosenberg Self-esteem Scale will be used to measure self-esteem in children who are part of the action group.
Measured: 6 months after the intervention
Motivation for implementation
The Motivation At Work Scale (MAWS) will be used to measure school staff's motivation for the implementation of the sleep intervention at school.
Measured: Baseline
Motivation for implementation
The Motivation At Work Scale (MAWS) will be used to measure school staff's motivation for the implementation of the sleep intervention at school.
Measured: Pre-intervention, after the co-creation process
Motivation for implementation
The Motivation At Work Scale (MAWS) will be used to measure school staff's motivation for the implementation of the sleep intervention at school.
Measured: Immediately after the intervention
Barriers for implementation
Based on findings of previous research questions were formulated regarding certain barriers that can appear during the implemtation of a school-based intervention.
Measured: Baseline
Barriers for implementation
Based on findings of previous research questions were formulated regarding certain barriers that can appear during the implemtation of a school-based intervention.
Measured: Pre-intervention, after the co-creation process
Barriers for implementation
Based on findings of previous research questions were formulated regarding certain barriers that can appear during the implemtation of a school-based intervention.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start4 Oct 2022
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sleep HygieneStudies 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
- The investigators aim to conduct a pilot three-arm controlled trial with a mixed methods approach. Schools will be assigned to one of three groups: 1) co-creation intervention group (shortened co-creation process), 2) standard implementation group (no co-creation process), and 3) control group. After the implementation of the intervention, effect and process will be evaluated.
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Maïté Verloigne, Prof. dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838339
- Sponsor's protocol ID
- ONZ-2022-0174
- Acronym
- Health CASCADE
- Status last verified
- Jun 2024
- First submitted
- 7 Nov 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share pseudonymized data within the Health CASCADE consortium and with fellow colleagues within the research group for secondary data analyses and teaching purposes. However, participants must re-consent for the use of their data in a new research project and domain.
Publications
Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.
PubMed 12841372Leask CF, Sandlund M, Skelton DA, Altenburg TM, Cardon G, Chinapaw MJM, De Bourdeaudhuij I, Verloigne M, Chastin SFM; GrandStand, Safe Step and Teenage Girls on the Move Research Groups. Framework, principles and recommendations for utilising participatory methodologies in the co-creation and evaluation of public health interventions. Res Involv Engagem. 2019 Jan 9;5:2. doi: 10.1186/s40900-018-0136-9. eCollection 2019.
PubMed 30652027Roenneberg T, Keller LK, Fischer D, Matera JL, Vetter C, Winnebeck EC. Human activity and rest in situ. Methods Enzymol. 2015;552:257-83. doi: 10.1016/bs.mie.2014.11.028. Epub 2015 Jan 5.
PubMed 25707281Sufrinko AM, Valrie CR, Lanzo L, Bond KE, Trout KL, Ladd RE, Everhart DE. Empirical validation of a short version of the Adolescent Sleep-Wake Scale using a sample of ethnically diverse adolescents from an economically disadvantage community. Sleep Med. 2015 Oct;16(10):1204-6. doi: 10.1016/j.sleep.2015.07.002. Epub 2015 Jul 15.
PubMed 26429746Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300Vandendriessche A, Dierckens M, Delaruelle K, Deforche B. How Are Adolescents Sleeping? Conservative Estimates of Sleep Duration Underestimate the Problem. J Adolesc Health. 2021 Apr;68(4):830. doi: 10.1016/j.jadohealth.2020.12.137. No abstract available.
PubMed 33781473Wood C, Griffin M, Barton J, Sandercock G. Modification of the Rosenberg Scale to Assess Self-Esteem in Children. Front Public Health. 2021 Jun 17;9:655892. doi: 10.3389/fpubh.2021.655892. eCollection 2021.
PubMed 34222169Soenens, B., Sierens, E., Vansteenkiste, M., Dochy, F., & Goossens, L. (2012). Psychologically controlling teaching: Examining outcomes, antecedents, and mediators. Journal of Educational Psychology, 104(1), 108-120. https://doi.org/10.1037/a0025742
Blais, M. R., Brière, N. M., Lachance, L., & Riddle, A. S. (1993). L'inventaire des motivations au travail de Blais. Revue québécoise de psychologie.
Delfmann LR, Vandendriessche A, de Boer J, Cardon G, Hunter SC, Dhondt K, Verloigne M, Deforche B. Co-adapting a healthy sleep intervention with adolescents: impact and process evaluation of a Health CASCADE pilot study. BMC Public Health. 2025 Nov 22;25(1):4411. doi: 10.1186/s12889-025-25412-2.
PubMed 41275198
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are You Daydreaming? Co-creation to Promote Healthy Sleep in Adolescents in a School Context: a Health CASCADE Protocol
- ClinicalTrials.gov ID
- NCT05838339
- Acronym / sponsor ID
- Health CASCADE / ONZ-2022-0174
- Conditions
- Sleep Hygiene, Sleep, Poor Quality Sleep
- Keywords
- Adolescence, Sleeping behavior, Co-creation, School-based intervention, School staff, Parents, Mental Health, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 1 May 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.
Health CASCADE (Marie Skłodowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. The current study, which focuses on co-creation in the school context is part of this overarching European project.
Healthy sleep is important for adolescents' mental and physical health and cognitive functioning. However, sleep difficulties are among the top three health complaints in European adolescents. This indicates a need for successful interventions.
Co-creation is a promising approach to design tailored interventions. By actively involving all relevant stakeholders, co-creation has been shown to increase self-efficacy, self-consciousness, empowerment, and feelings of ownership. However, co-created interventions are localized and therefore less generalizable to a broader population. Moreover, the process is very time- and cost- consuming. To make co-creation more feasible, research should focus on the upscaling of existing interventions. The investigators propose that the co-creation process is still absolutely vital for intervention success but that it can be shortened.
The investigators aim to scale up an existing intervention to promote healthy sleep. This existing intervention was developed using co-creation together with the target group (adolescents aged 13 to 15) and parents, and implemented with support of teachers and fellow students. To investigate whether the shorter co-creation process is needed in order to scale up the intervention to another setting and context, the investigators will use a three-arm cluster controlled trial. This will include one co-creation intervention school, one standard implementation school (this school receives the existing intervention without a shortened co-creation process), and one control school. The co-creation process will be structured by using the Intervention Mapping Protocol to ensure an evidence-based framework. The effect of the intervention will be evaluated using actigraphy and questionnaires, while the process will be evaluated using questionnaires, interviews, and focus groups.
Detailed description
The aim of this study is to scale up an existing sleep intervention (co-created with adolescents and parents, and implemented with the support of teachers and fellow students) in Flanders to improve sleeping behavior. Scaling up an intervention is defined as transferring an intervention to another context, setting, and group. As co-created interventions are localized by nature, the researchers will investigate whether this existing intervention can be scaled up to a new context, setting, and group while the aim of the intervention remains the same, i.e., improving healthy sleeping behavior in adolescents. To test this, a co-creation school, standard implementation school, and control school will be recruited. Below, the investigators will describe what will be expected from each condition.
Co-creation school: Scaling up the existing sleep intervention to a new context, setting, and group will proceed in the co-creation school. The existing intervention will be adapted to the culture of this school, based on students', school staff's, and parents' perspective on the health problem (unhealthy sleeping behavior in adolescents) and thoughts on the components of the existing intervention. To adapt the existing sleep intervention, action groups will be composed. Every action group contains a maximum of 10 individuals.
- Action group adolescents: This action group consists of a maximum of 10 students from the 6th and 7th grade (1st grade secondary school, Belgian school system). The participants will be involved in the adaptation of existing intervention components. Furthermore, participants will implement the adapted intervention at school.
- Action group school staff: This action group consists of a maximum of 10 individuals working at the co-creation school. Participants will be involved in designing an implementation plan for the intervention. Moreover, participants will be asked to check the adapted components for feasibility.
- Action group parents: This action group consists of a maximum of 10 parents who have at least one child in the 6th or 7th grade of the co-creation school. Parents will be involved in the adaptation of the parental intervention components of the existing intervention.
- Co-facilitators: Students of the 12th grade (year 6 secondary school, Belgian school system) will be involved as co-facilitators. This means that the students of the 12th grade will facilitate the co-creation sessions designed for the students of the 6th and 7th grade together with the researchers.
Standard implementation school: To test the added value of the shortened co-creation process and to show that this process is needed to build ownership and empowerment, the existing sleep intervention will be implemented without the shortened co-creation process. The standard implementation school will be provided with a manual and a training about the implementation of the intervention.
Control school: To test the overall effect of the intervention a control group is needed. None of the interventions will be implemented at the control school and therefore the school staff do not have to take part in the measurements.
In total, the intervention in both the co-creation school and the standard implementation school will take 9 weeks.
Effect evaluation: To test the effect of the intervention, students (n = 378, based on a power analysis performed in R) will be invited to take part in three measurements (baseline, posttest (after the intervention), and follow-up (sixth months after the end of the intervention)) in all three arms. For members of the action group, a fourth measure will be administered (in-between baseline and posttest) to investigate whether the co-creation process itself can lead to changes in specific variables (see measures section). In order to compare the co-creation process to a standard implementation training, this fourth measurement will also be assessed among individuals involved in the implementation in the standard implementation school. To objectively measure sleep, participants will be asked to wear a GENEActiv device for 7 consecutive days at each of the three measurement points. Furthermore, participants will be invited to complete a questionnaire. This questionnaire will consist of questions about sleep duration, sleep quality, daytime sleepiness, sleep hygiene, determinants of sleeping behavior (knowledge, attitude, self-efficacy specifically related to sleeping behavior, social influence and social support, barriers), mental wellbeing, and feelings of empowerment and ownership. Furthermore, SES, puberty, and BMI will be assessed as important covariates. For students who are part of the action group (in the co-creation school) the questionnaire will also contain questions about general self-efficacy, and self-esteem. Moreover, students who are part of the action group will be invited to complete the whole questionnaire at one additional time point, namely after the shortened co-creation process. This measurement will enable us to investigate whether students in the action group experience more general self-efficacy and feelings of self-esteem as a result of participation in the co-creation process. Parents (ideally n = 378, one parent of each participating student) will be invited to complete questionnaires at the same measurement points as the students in all three arms. Parents' questionnaire will contain questions about knowledge and attitude about sleep, whether parents impose bedtime rules on children or have other supportive strategies, and questions regarding self-efficacy in engaging in these supportive strategies. Completion of questionnaires for students will take about one lesson (40-50 minutes). For parents, completion will take about 15 minutes.
Process evaluation: To evaluate the co-creation process as well as the implementation of the intervention, the investigators will use questionnaires, interviews, and focus groups. Students and parents from the action group will be asked to provide a short evaluation after every co-creation session. More extensive evaluations (focus group) will take place half-way during the development of the intervention, once the adaptation of the intervention is finished, and after the implementation of the intervention is done. Fellow students and parents, who are not part of the action group will be asked to evaluate the implementation of the intervention as well, using a short questionnaire. Students will also be invited to take part in focus groups. School staff (co-creation arm and standard implementation arm) will be invited to complete a questionnaire measuring motivation, empowerment, barriers for implementation, and general knowledge about sleep at three time points (baseline, pre-implementation, and after the intervention). Completion of questionnaires for school staff will take about 30 minutes. Moreover, school staff will be invited to take part in focus groups as well. These will take place at the same time points as for the students. Focus groups will take around 50 minutes (one lesson).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators aim to conduct a pilot three-arm controlled trial with a mixed methods approach. Schools will be assigned to one of three groups: 1) co-creation intervention group (shortened co-creation process), 2) standard implementation group (no co-creation process), and 3) control group. After the implementation of the intervention, effect and process will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Co-creation School | Experimental | Behavioral: Healthy Sleep InterventionAn existing healthy sleep intervention will be scaled up using a shortened co-creation process. An effect- and process evaluation will be performed. |
| Standard Implementation School | Active comparator | Behavioral: Healthy Sleep InterventionThe existing healthy sleep intervention will be implemented without using a co-creation approach. An effect- and process evaluation will be performed. |
| Control School | No intervention | –No intervention will be implemented. An effect evaluation will be performed. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Students must be aged between 11 and 13 years. Parents must have at least one child in the 6th or 7th Grade of the participating school.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Healthy Sleep InterventionThe existing intervention consists of the following components: Posters, Instagram, kick-off event, flyer for parents, parents-teacher conference, class discussions, app, classes on sleep (and relaxation), blue lights installations, alarm clocks and t-shirts, T-days without phone in the bedroom (Tuesdays and Thursdays), class competition. | Behavioural | Co-creation School, Standard Implementation School |
Primary outcome
Sleep quantity school days
Time frame: Baseline
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Sleep quantity free days
Time frame: Baseline
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Sleep quantity school days
Time frame: Pre-intervention, after the co-creation process
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4). The pre-intervention assessment will only be done for members of the action group.
Sleep quantity free days
Time frame: Pre-intervention, after the co-creation process
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4). The pre-intervention assessment will only be done for members of the action group.
Sleep quantity school days
Time frame: Immediately after the intervention
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Sleep quantity free days
Time frame: Immediately after the intervention
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Sleep quantity school days
Time frame: 6 months after the intervention
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Sleep quantity free days
Time frame: 6 months after the intervention
Will be assessed using the Munich Chronotype Questionnaire for Children (MCTQ). Sleep onset will be calculated by adding the time of trying to go to sleep (item 2) and the time it really takes to fall asleep (item 3). Then, sleep quantity will be computed by calculating the difference between sleep onset and the time of waking up (item 4).
Objective sleep quantity school days
Time frame: Baseline
Will be assessed objectively using actigraphy (GENEActivs)
Objective sleep quantity free days
Time frame: Baseline
Will be assessed objectively using actigraphy (GENEActivs)
Objective sleep quantity school days
Time frame: Pre-intervention, after the co-creation process
Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.
Objective sleep quantity free days
Time frame: Pre-intervention, after the co-creation process
Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.
Objective sleep quantity school days
Time frame: Immediately after the intervention
Will be assessed objectively using actigraphy (GENEActivs)
Objective sleep quantity free days
Time frame: Immediately after the intervention
Will be assessed objectively using actigraphy (GENEActivs)
Objective sleep quantity school days
Time frame: 6 months after the intervention
Will be assessed objectively using actigraphy (GENEActivs)
Objective sleep quantity free days
Time frame: 6 months after the intervention
Will be assessed objectively using actigraphy (GENEActivs)
Sleep quality - general
Time frame: Baseline
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS)
Sleep quality - daytime sleepiness
Time frame: Baseline
Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS)
Sleep quality school days - SOL
Time frame: Baseline
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Sleep quality free days - SOL
Time frame: Baseline
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Objective sleep quality
Time frame: Baseline
Will be assessed objectively using actigraphy (GENEActivs)
Sleep quality - general
Time frame: Pre-intervention, after the co-creation process
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS). The pre-intervention assessment will only be done for members of the action group.
Sleep quality - daytime sleepiness
Time frame: Pre-intervention, after the co-creation process
Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS). The pre-intervention assessment will only be done for members of the action group.
Sleep quality school days - SOL
Time frame: Pre-intervention, after the co-creation process
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ. The pre-intervention assessment will only be done for members of the action group.
Sleep quality free days - SOL
Time frame: Pre-intervention, after the co-creation process
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ. The pre-intervention assessment will only be done for members of the action group.
Objective sleep quality
Time frame: Pre-intervention, after the co-creation process
Will be assessed objectively using actigraphy (GENEActivs). The pre-intervention assessment will only be done for members of the action group.
Sleep quality - general
Time frame: Immediately after the intervention
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS).
Sleep quality - daytime sleepiness
Time frame: Immediately after the intervention
Will be assessed using the Pediatric Daytime Sleepiness Scale (PDSS)
Sleep quality school days - SOL
Time frame: Immediately after the intervention
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Sleep quality free days - SOL
Time frame: Immediately after the intervention
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Objective sleep quality
Time frame: Immediately after the intervention
Will be assessed objectively using actigraphy (GENEActivs)
Sleep quality - general
Time frame: 6 months after the intervention
Will be assessed using the short form of the Adolescent Sleep Wake Scale (s-ASWS)
Sleep quality - daytime sleepiness
Time frame: 6 months after the intervention
Will be assessed using the Pediatric Daytime Sleepiness Scale
Sleep quality school days - SOL
Time frame: 6 months after the intervention
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Sleep quality free days - SOL
Time frame: 6 months after the intervention
Will be assessed with Sleep Onset Latency (SOL), item 3 of the MCTQ
Objective sleep quality
Time frame: 6 months after the intervention
Will be assessed objectively using actigraphy (GENEActivs)
29 secondary outcomes
Determinants of sleeping behavior
Time frame: Baseline
Determinants of sleeping behavior
Time frame: Pre-intervention, after the co-creation process
Determinants of sleeping behavior
Time frame: Immediately after the intervention
Determinants of sleeping behavior
Time frame: 6 months after the intervention
Mental wellbeing
Time frame: Baseline
Mental wellbeing
Time frame: Pre-intervention, after the co-creation process
Mental wellbeing
Time frame: Immediately after the intervention
Mental wellbeing
Time frame: 6 months after the intervention
Self-efficacy
Time frame: Baseline
Self-efficacy
Time frame: Pre-intervention, after the co-creation process
Self-efficacy
Time frame: Immediately after the intervention
Self-efficacy
Time frame: 6 months after the intervention
Empowerment
Time frame: Baseline
Empowerment
Time frame: Pre-intervention, after the co-creation process
Empowerment
Time frame: Immediately after the intervention
Empowerment
Time frame: 6 months after the intervention
General motivation
Time frame: Baseline
General motivation
Time frame: Pre-intervention, after the co-creation process
General motivation
Time frame: Immediately after the intervention
Self-esteem
Time frame: Baseline
Self-esteem
Time frame: Pre-intervention, after the co-creation process
Self-esteem
Time frame: Immediately after the intervention
Self-esteem
Time frame: 6 months after the intervention
Motivation for implementation
Time frame: Baseline
Motivation for implementation
Time frame: Pre-intervention, after the co-creation process
Motivation for implementation
Time frame: Immediately after the intervention
Barriers for implementation
Time frame: Baseline
Barriers for implementation
Time frame: Pre-intervention, after the co-creation process
Barriers for implementation
Time frame: Immediately after the 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 1 Oct 2024.
- Background: PubMed 12841372Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.
- Background: PubMed 30652027Leask CF, Sandlund M, Skelton DA, Altenburg TM, Cardon G, Chinapaw MJM, De Bourdeaudhuij I, Verloigne M, Chastin SFM; GrandStand, Safe Step and Teenage Girls on the Move Research Groups. Framework, principles and recommendations for utilising participatory methodologies in the co-creation and evaluation of public health interventions. Res Involv Engagem. 2019 Jan 9;5:2. doi: 10.1186/s40900-018-0136-9. eCollection 2019.
- Background: PubMed 25707281Roenneberg T, Keller LK, Fischer D, Matera JL, Vetter C, Winnebeck EC. Human activity and rest in situ. Methods Enzymol. 2015;552:257-83. doi: 10.1016/bs.mie.2014.11.028. Epub 2015 Jan 5.
- Background: PubMed 26429746Sufrinko AM, Valrie CR, Lanzo L, Bond KE, Trout KL, Ladd RE, Everhart DE. Empirical validation of a short version of the Adolescent Sleep-Wake Scale using a sample of ethnically diverse adolescents from an economically disadvantage community. Sleep Med. 2015 Oct;16(10):1204-6. doi: 10.1016/j.sleep.2015.07.002. Epub 2015 Jul 15.
- Background: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Background: PubMed 33781473Vandendriessche A, Dierckens M, Delaruelle K, Deforche B. How Are Adolescents Sleeping? Conservative Estimates of Sleep Duration Underestimate the Problem. J Adolesc Health. 2021 Apr;68(4):830. doi: 10.1016/j.jadohealth.2020.12.137. No abstract available.
- Background: PubMed 34222169Wood C, Griffin M, Barton J, Sandercock G. Modification of the Rosenberg Scale to Assess Self-Esteem in Children. Front Public Health. 2021 Jun 17;9:655892. doi: 10.3389/fpubh.2021.655892. eCollection 2021.
- BackgroundSoenens, B., Sierens, E., Vansteenkiste, M., Dochy, F., & Goossens, L. (2012). Psychologically controlling teaching: Examining outcomes, antecedents, and mediators. Journal of Educational Psychology, 104(1), 108-120. https://doi.org/10.1037/a0025742
- BackgroundBlais, M. R., Brière, N. M., Lachance, L., & Riddle, A. S. (1993). L'inventaire des motivations au travail de Blais. Revue québécoise de psychologie.
- Derived from this study: PubMed 41275198Delfmann LR, Vandendriessche A, de Boer J, Cardon G, Hunter SC, Dhondt K, Verloigne M, Deforche B. Co-adapting a healthy sleep intervention with adolescents: impact and process evaluation of a Health CASCADE pilot study. BMC Public Health. 2025 Nov 22;25(1):4411. doi: 10.1186/s12889-025-25412-2.
- Basic psychological need satisfaction need frustration scaleLink provided by the sponsor.
- General Self-efficacy ScaleLink provided by the sponsor.
- Adolescent health and wellbeingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators plan to share pseudonymized data within the Health CASCADE consortium and with fellow colleagues within the research group for secondary data analyses and teaching purposes. However, participants must re-consent for the use of their data in a new research project and domain.
Related trials for Sleep Hygiene
Not yet recruiting
AI-Powered Sleep Hygiene Mentor for Adults Living With HIV
Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Enrolling by invitation
Brief Behavioral Therapy for Insomnia (BBTi) in Middle-aged and Older Adults With Chronic Insomnia
Chronic Insomnia, Older Adults
Recruiting
Sleep Better, Live Better Study
Sleep Hygiene, Sleep Duration
Recruiting
Online Sleep Education for College Student's Sleep Health and Executive Functioning
Sleep, Executive Functioning
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.
Maïté Verloigne, Prof. dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Sleep Intervention in people with Sleep Hygiene and Sleep, run by University Ghent at 1 site in Belgium.
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 1 Oct 2024. 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 Belgium. 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?
Sleep quantity school days (time frame: Baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838339, which also lists 10 linked publications.
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 1 Oct 2024.