Sleep Disorder Circadian Rhythm, Delayed Sleep Phase TypeSleepHelNCT02964598
SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
A study testing Gamified intervention, Sleep coaching and Bright light in people with Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type, run by University of Helsinki at 1 site in Finland.
Trial summary
Adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. Simultaneously external pressures, such as evening-driven social activities increase. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type
- What is being tested?
- Gamified intervention, Sleep coaching and Bright light
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Late bedtime several times per week
Who cannot join
- Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
Adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. Simultaneously external pressures, such as evening-driven social activities increase. These may lead to delayed sleep phase, which may cause serious problems for waking up at socially accepted times, and absenteeism from the school may follow. This project aims at tracking risk factors for later circadian regulation problems, characterizing interconnections of biological, psychological and behavioural mechanisms that maintain or induce poor sleep regulation in adolescence, and building a cost-effective, theoretically-based sleep intervention for adolescents with delayed sleep phase. This randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.
- Being tested
- Gamified intervention, Sleep coaching, Bright light, Control, Psychoeducation
- Keywords
- Adolescent, Population-based, Social jetlag, Intervention, Bright light, Motivation, Circadian regulation, Behavioral change
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified interventionBehavioural
Also called Helsinki Sleep Factory
A new mobile application for assisting in sleep regulation, duration 4-6 weeks
Sleep coachingBehavioural
A new personalized program, duration 4-6 weeks
Bright lightDevice
Morning bright light 10 000 lux maximum duration 4-6 weeks
ControlOther
Minimal information on sleep timing and advancing the sleep rhythm
PsychoeducationOther
An extensive information platform in the internet created for this purpose
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Minimal information on sleep timing Receives: Other: Control |
| Psychoeducation | Experimental | An extensive psychoeducational platform Receives: Other: Psychoeducation |
| Bright light | Experimental | Bright light treatment with 10 000 lux at max Receives: Device: Bright light |
| Gamified intervention | Experimental | A new gamified intervention designed for mobile phones Receives: Behavioral: Gamified intervention |
| Bright light and gamified intervention | Experimental | A combination of the two Receives: Behavioral: Gamified intervention; Device: Bright light |
| Sleep coaching | Experimental | A new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior Receives: Behavioral: Sleep coaching |
| Sleep coaching + bright light | Experimental | A combination of the two Receives: Behavioral: Sleep coaching; Device: Bright light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian sleep rhythm
Actigraphy (brand GeneActiv)
Measured: 8 weeks
Circadian body temperature rhythm
iButton measurement from the wrist
Measured: 8 weeks
Secondary outcomes (5)
Mood
Experience sampling method, brand Psymate
Measured: 8 weeks
Insomnia symptoms
Bergen Insomnia Scale
Measured: 8 weeks
Sleep problems
Pittsburgh Sleep Quality Index
Measured: 8 weeks
Depression
Beck Depression Inventory
Measured: 8 weeks
Anxiety
Generalized Anxiety Disorder questionnaire GAD-7
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorder Circadian Rhythm, Delayed Sleep Phase TypeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland
- Responsible party
- Principal investigator, Anu-Katriina Pesonen, University of Helsinki
- Investigators
- Anu-Katriina Pesonen, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964598
- Sponsor's protocol ID
- 1287174
- Acronym
- SleepHel
- Status last verified
- Nov 2016
- First submitted
- 9 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kuula L, Pesonen AK. Toward Earlier Bedtimes: Randomized Trial of Multi-Method Interventions in a Community Cohort of Adolescents. J Adolesc Health. 2026 Jun;78(6):854-864. doi: 10.1016/j.jadohealth.2025.12.247. Epub 2026 Feb 16.
PubMed 41697175
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
- ClinicalTrials.gov ID
- NCT02964598
- Acronym / sponsor ID
- SleepHel / 1287174
- Keywords
- Adolescent, Population-based, Social jetlag, Intervention, Bright light, Motivation, Circadian regulation, Behavioral change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Academy of Finland
- Study start
- Nov 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- 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.
Adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. Simultaneously external pressures, such as evening-driven social activities increase. These may lead to delayed sleep phase, which may cause serious problems for waking up at socially accepted times, and absenteeism from the school may follow. This project aims at tracking risk factors for later circadian regulation problems, characterizing interconnections of biological, psychological and behavioural mechanisms that maintain or induce poor sleep regulation in adolescence, and building a cost-effective, theoretically-based sleep intervention for adolescents with delayed sleep phase. This randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlMinimal information on sleep timing |
| Psychoeducation | Experimental | Other: PsychoeducationAn extensive psychoeducational platform |
| Bright light | Experimental | Device: Bright lightBright light treatment with 10 000 lux at max |
| Gamified intervention | Experimental | Behavioral: Gamified interventionA new gamified intervention designed for mobile phones |
| Bright light and gamified intervention | Experimental | Behavioral: Gamified intervention, Device: Bright lightA combination of the two |
| Sleep coaching | Experimental | Behavioral: Sleep coachingA new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior |
| Sleep coaching + bright light | Experimental | Behavioral: Sleep coaching, Device: Bright lightA combination of the two |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Late bedtime several times per week
Key exclusion criteria (1 listed)
- Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant
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 |
|---|---|---|
| Gamified interventionAlso: Helsinki Sleep FactoryA new mobile application for assisting in sleep regulation, duration 4-6 weeks | Behavioural | Bright light and gamified intervention, Gamified intervention |
| Sleep coachingA new personalized program, duration 4-6 weeks | Behavioural | Sleep coaching, Sleep coaching + bright light |
| Bright lightMorning bright light 10 000 lux maximum duration 4-6 weeks | Device | Bright light, Bright light and gamified intervention, Sleep coaching + bright light |
| ControlMinimal information on sleep timing and advancing the sleep rhythm | Other | Control |
| PsychoeducationAn extensive information platform in the internet created for this purpose | Other | Psychoeducation |
Primary outcome
Circadian sleep rhythm
Time frame: 8 weeks
Actigraphy (brand GeneActiv)
Circadian body temperature rhythm
Time frame: 8 weeks
iButton measurement from the wrist
5 secondary outcomes
Mood
Time frame: 8 weeks
Insomnia symptoms
Time frame: 8 weeks
Sleep problems
Time frame: 8 weeks
Depression
Time frame: 8 weeks
Anxiety
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 41697175Kuula L, Pesonen AK. Toward Earlier Bedtimes: Randomized Trial of Multi-Method Interventions in a Community Cohort of Adolescents. J Adolesc Health. 2026 Jun;78(6):854-864. doi: 10.1016/j.jadohealth.2025.12.247. Epub 2026 Feb 16.
- 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.
Anu-Katriina Pesonen, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified intervention, Sleep coaching and Bright light in people with Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type, run by University of Helsinki at 1 site in Finland.
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: status not confirmed, as of the sponsor's last update on 16 Nov 2016. 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 Finland. 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?
Results are not available in the source record.
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?
Circadian sleep rhythm (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964598, which also lists 1 linked publication.
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 16 Nov 2016.