SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE (SleepHel)

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type
• Intervention / Treatment: Other: Control; Other: Psychoeducation; Device: Bright light; Behavioral: Gamified intervention; Behavioral: Sleep coaching

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • University of Helsinki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Academy of Finland
• Investigators: Principal Investigator: Anu-Katriina Pesonen, PhD, University of Helsinki

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 11, 2016
• First Posted (ESTIMATE): November 16, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 11, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Adolescent; Motivation; Intervention; Behavioral change; Population-based; Bright light; Social jetlag; Circadian regulation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 1287174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO