Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)

February 11, 2026 updated by: Saskia Van der Oord, Universitaire Ziekenhuizen KU Leuven

SIESTA Sleep IntervEntion as Symptom Treatment for ADHD - Blended CBT Sleep Intervention to Improve Sleep, ADHD Symptoms and Related Problems in Adolescents With ADHD

Up to 72% of adolescents with ADHD portray sleep problems. The most common sleep difficulties in adolescents with ADHD are initial insomnia, nocturnal awakenings, non-restorative or restless sleep. These difficulties seem to be causally related to increased ADHD symptom impairment, oppositional and depressive symptomatology, and functional impairments in daily life, resulting in a vicious circle of sleep problems and impairment. Thus, reducing sleep problems is an important intervention target. However, to date there is no evidence-based cognitive behavioral sleep treatment available. Sleep-focused treatments need adaptation towards this developmental phase/disorder for effectiveness, as ADHD and sleep problems are bi-directional. Therefore, a blended treatment targeting the core deficits integrating motivational interviewing, planning skills and sleep interventions is needed. Thus, the aim of this project is testing the short and 3-4 months follow-up effectiveness of the blended cognitive behavioral sleep intervention in adolescents with ADHD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To test effectiveness a randomized controlled trial in conducted in which adolescents with ADHD and sleep problems are randomized to either their Treatment as Usual for ADHD or their Treatment as usual for ADHD combined with the SIESTA cognitive behavioral sleep interventions. Effects on sleep, ADHD behavior and co-occuring problems are assessed at pretest, post test and at 3-4 months follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UPC Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Attending secondary education and between 13-17 years old
  2. prior diagnosis of ADHD (any presentation) and confirmation of DSM-5 criteria of ADHD in current study

  3. Displaying sleep problems for at least 3 nights per week for at least 3 months

    1. sleep onset latency of at least 20-30 minutes
    2. and/or wake after sleep onset greater than 30 min
    3. and/or an average sleep time of less than 7 hours
    4. and at least one poor sleep hygiene practice
    5. and experienced distress as indicated by parent/guardian and/or adolescent.
  4. estimated IQ≥80
  5. stable ADHD medication use at least 4 weeks before start of treatment and no dose or medication type changes planned during active treatment

Exclusion Criteria:

  1. the following comorbidities: sleep-breathing disorder, restless leg syndrome, narcolepsy, conduct disorder, depressive disorder with suicide risk or active suicidality, autism spectrum disorder, or substance use disorder, with an exception for nicotine
  2. acute crisis situation at home
  3. physical problems that interfere with sleep (e.g. pain) or medical disorders and related medication that could affect sleep
  4. participation in a behaviorally based sleep intervention in the 6 months prior to our study
  5. currently taking pharmacological medication for sleep (including melatonin), anxiety or depression. Participation will be allowed after a two-week wash-out period of the medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SIESTA training + treatment as usual for ADHD
We developed a cognitive behavioral therapy for sleep problems in adolescents with ADHD. This includes seven individual sessions with the adolescent and two individual sessions with the parent(s)/guardian(s). Participants receive this CBT training called SIESTA next to their treatment as usual for ADHD symptomatology (mostly ADHD-medication).
Behavioral: SIESTA
SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.
Other Names:
  • Sleep IntervEntion as Symptom Treatment for ADHD
Other: Treatment as usual for ADHD
Participants continue their treatment as usual for ADHD.
Other Names:
  • TAU
Active Comparator: Treatment as usual for ADHD only
Participants continue their treatment as usual for ADHD (mostly ADHD-medication).
Other: Treatment as usual for ADHD
Participants continue their treatment as usual for ADHD.
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test
Time Frame: From pre-test to post-test (+/-8 weeks)
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
From pre-test to post-test (+/-8 weeks)
Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Sleep architecture objective (actigraphy) sleep architecture (specified as Number of Awakenings)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings)
From pre-test to post-test (+- 8 weeks)
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as NoA: Number of Awakenings)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
From pre-test to follow-up (+-3 months after posttest)
Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings)
From pre-test to follow-up (+-3 months after posttest)
Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50
From pre-test to post-test (+- 8 weeks)
Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60
From pre-test to post-test (+- 8 weeks)
Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99
From pre-test to post-test (+- 8 weeks)
Sleep Problems SSHS [School Sleep Habits Survey] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50
From pre-test to follow-up (+-3 months after posttest)
Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60
From pre-test to follow-up (+-3 months after posttest)
Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99
From pre-test to follow-up (+-3 months after posttest)
ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6
From pre-test to post-test (+- 8 weeks)
ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6
From pre-test to follow-up (+-3 months after posttest)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54
From pre-test to post-test (+- 8 weeks)
DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54
From pre-test to follow-up (+-3 months after posttest)
CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome
From pre-test to post-test (+- 8 weeks)
CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome
From pre-test to follow-up (+-3 months after posttest)
HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)

Assessed by parents (HPC)

: rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome
From pre-test to post-test (+- 8 weeks)
CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome
From pre-test to post-test (+- 8 weeks)
HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)

Assessed by parents (HPC)

Homework Problems Checklist: rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome
From pre-test to follow-up (+-3 months after posttest)
CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome
From pre-test to follow-up (+-3 months after posttest)
DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome
From pre-test to post-test (+- 8 weeks)
SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome
From pre-test to post-test (+- 8 weeks)
CDI [Children's Depression Inventory] Depression Pre-test to Post-test
Time Frame: From pre-test to post-test (+- 8 weeks)
Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome
From pre-test to post-test (+- 8 weeks)
DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome
From pre-test to follow-up (+-3 months after posttest)
SCARED-R [Screen for Child Anxiety Related Emotional Disorders] Anxiety Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome
From pre-test to follow-up (+-3 months after posttest)
CDI [Children's Depression Inventory] Depression Pre-test to Follow-up
Time Frame: From pre-test to follow-up (+-3 months after posttest)
Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome
From pre-test to follow-up (+-3 months after posttest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven
Research Foundation Flanders

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saskia Van der Oord, PhD, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UZ Leuven (UZ leuven)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be stored in the data repository of the KU Leuven (research data repository https://rdr.kuleuven.be/). Upon request of researchers (see below for access criteria) anonymous data will be shared by secured transfer to other researchers

IPD Sharing Time Frame

Data will be shared from May 2025 (all data processed/ RCT paper written). Data is available for 25 years after publication of our RCT paper.

IPD Sharing Access Criteria

All relevant pre-post and follow-up individual participant data outcomes of all adolescents (and their parents) that provided informed consent/participated in our study will be shared with researchers that are conducting an IPD meta-analysis or researchers thar are assessing another relevant research question. Before transfer data will be completely anonymized to the researchers that will receive the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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