SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE

Conditions
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Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type

Intervention / Treatment
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* Behavioral: Gamified intervention
* Behavioral: Sleep coaching
* Device: Bright light
* Other: Control
* Other: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Late bedtime several times per week Exclusion Criteria: Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Minimal information on sleep timing | Other: Control<br>* Minimal information on sleep timing and advancing the sleep rhythm<br>|
| Experimental: Psychoeducation<br>An extensive psychoeducational platform | Other: Psychoeducation<br>* An extensive information platform in the internet created for this purpose<br>|
| Experimental: Bright light<br>Bright light treatment with 10 000 lux at max | Device: Bright light<br>* Morning bright light 10 000 lux maximum duration 4-6 weeks<br>|
| Experimental: Gamified intervention<br>A new gamified intervention designed for mobile phones | Behavioral: Gamified intervention<br>* A new mobile application for assisting in sleep regulation, duration 4-6 weeks<br>* Other names: Helsinki Sleep Factory;|
| Experimental: Bright light and gamified intervention<br>A combination of the two | Behavioral: Gamified intervention<br>* A new mobile application for assisting in sleep regulation, duration 4-6 weeks<br>* Other names: Helsinki Sleep Factory;Device: Bright light<br>* Morning bright light 10 000 lux maximum duration 4-6 weeks<br>|
| Experimental: Sleep coaching<br>A new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior | Behavioral: Sleep coaching<br>* A new personalized program, duration 4-6 weeks<br>|
| Experimental: Sleep coaching + bright light<br>A combination of the two | Behavioral: Sleep coaching<br>* A new personalized program, duration 4-6 weeks<br>Device: Bright light<br>* Morning bright light 10 000 lux maximum duration 4-6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian sleep rhythm | Actigraphy (brand GeneActiv) | 8 weeks | 
| Circadian body temperature rhythm | iButton measurement from the wrist | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Experience sampling method, brand Psymate | 8 weeks | 
| Insomnia symptoms | Bergen Insomnia Scale | 8 weeks | 
| Sleep problems | Pittsburgh Sleep Quality Index | 8 weeks | 
| Depression | Beck Depression Inventory | 8 weeks | 
| Anxiety | Generalized Anxiety Disorder questionnaire GAD-7 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Population-based, Social jetlag, Intervention, Bright light, Motivation, Circadian regulation, Behavioral change