NCT02964598

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

November 9, 2016

Last Update Submit

November 11, 2016

Conditions

Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type

Keywords

AdolescentPopulation-basedSocial jetlagInterventionBright lightMotivationCircadian regulationBehavioral change

Outcome Measures

Primary Outcomes (2)

  • Circadian sleep rhythm

    Actigraphy (brand GeneActiv)

    8 weeks

  • Circadian body temperature rhythm

    iButton measurement from the wrist

    8 weeks

Secondary Outcomes (5)

  • Mood

    8 weeks

  • Insomnia symptoms

    8 weeks

  • Sleep problems

    8 weeks

  • Depression

    8 weeks

  • Anxiety

    8 weeks

Study Arms (7)

Control

EXPERIMENTAL

Minimal information on sleep timing

Other: Control

Psychoeducation

EXPERIMENTAL

An extensive psychoeducational platform

Other: Psychoeducation

Bright light

EXPERIMENTAL

Bright light treatment with 10 000 lux at max

Device: Bright light

Gamified intervention

EXPERIMENTAL

A new gamified intervention designed for mobile phones

Behavioral: Gamified intervention

Bright light and gamified intervention

EXPERIMENTAL

A combination of the two

Behavioral: Gamified interventionDevice: Bright light

Sleep coaching

EXPERIMENTAL

A new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior

Behavioral: Sleep coaching

Sleep coaching + bright light

EXPERIMENTAL

A combination of the two

Behavioral: Sleep coachingDevice: Bright light

Interventions

Gamified interventionBEHAVIORAL

A new mobile application for assisting in sleep regulation, duration 4-6 weeks

Also known as: Helsinki Sleep Factory
Bright light and gamified interventionGamified intervention
Sleep coachingBEHAVIORAL

A new personalized program, duration 4-6 weeks

Sleep coachingSleep coaching + bright light
Bright lightDEVICE

Morning bright light 10 000 lux maximum duration 4-6 weeks

Bright lightBright light and gamified interventionSleep coaching + bright light
ControlOTHER

Minimal information on sleep timing and advancing the sleep rhythm

Control
PsychoeducationOTHER

An extensive information platform in the internet created for this purpose

Psychoeducation

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Late bedtime several times per week

You may not qualify if:

  • Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki

Helsinki, Helsinki, Finland

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Officials

  • Anu-Katriina Pesonen, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 16, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)