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SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE (SleepHel)

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ClinicalTrials.gov Identifier: NCT02964598
Recruitment Status : Unknown
Verified November 2016 by Anu-Katriina Pesonen, Helsinki University.
Recruitment status was:  Enrolling by invitation
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Anu-Katriina Pesonen, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type Behavioral: Gamified intervention Behavioral: Sleep coaching Device: Bright light Other: Control Other: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: Helsinki Sleep Factory

Experimental: Bright light and gamified intervention
A combination of the two
Behavioral: Gamified intervention
A new mobile application for assisting in sleep regulation, duration 4-6 weeks
Other Name: Helsinki Sleep Factory

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

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
Behavioral: Sleep coaching
A new personalized program, duration 4-6 weeks

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




Primary Outcome Measures :
  1. Circadian sleep rhythm [ Time Frame: 8 weeks ]
    Actigraphy (brand GeneActiv)

  2. Circadian body temperature rhythm [ Time Frame: 8 weeks ]
    iButton measurement from the wrist


Secondary Outcome Measures :
  1. Mood [ Time Frame: 8 weeks ]
    Experience sampling method, brand Psymate

  2. Insomnia symptoms [ Time Frame: 8 weeks ]
    Bergen Insomnia Scale

  3. Sleep problems [ Time Frame: 8 weeks ]
    Pittsburgh Sleep Quality Index

  4. Depression [ Time Frame: 8 weeks ]
    Beck Depression Inventory

  5. Anxiety [ Time Frame: 8 weeks ]
    Generalized Anxiety Disorder questionnaire GAD-7



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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964598


Locations
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Finland
University of Helsinki
Helsinki, Finland
Sponsors and Collaborators
Helsinki University
Academy of Finland
Investigators
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Principal Investigator: Anu-Katriina Pesonen, PhD Helsinki University

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Responsible Party: Anu-Katriina Pesonen, Professor, Helsinki University
ClinicalTrials.gov Identifier: NCT02964598     History of Changes
Other Study ID Numbers: 1287174
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anu-Katriina Pesonen, Helsinki University:
Adolescent
Population-based
Social jetlag
Intervention
Bright light
Motivation
Circadian regulation
Behavioral change
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases