Back to resultsSleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE (SleepHel)
Primary Purpose
Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Gamified intervention
Sleep coaching
Bright light
Control
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type focused on measuring Adolescent, Population-based, Social jetlag, Intervention, Bright light, Motivation, Circadian regulation, Behavioral change
Eligibility 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
Sites / Locations
- University of Helsinki
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Control
Psychoeducation
Bright light
Gamified intervention
Bright light and gamified intervention
Sleep coaching
Sleep coaching + bright light
Arm Description
Minimal information on sleep timing
An extensive psychoeducational platform
Bright light treatment with 10 000 lux at max
A new gamified intervention designed for mobile phones
A combination of the two
A new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior
A combination of the two
Outcomes
Primary Outcome Measures
Circadian sleep rhythm
Actigraphy (brand GeneActiv)
Circadian body temperature rhythm
iButton measurement from the wrist
Secondary Outcome Measures
Mood
Experience sampling method, brand Psymate
Insomnia symptoms
Bergen Insomnia Scale
Sleep problems
Pittsburgh Sleep Quality Index
Depression
Beck Depression Inventory
Anxiety
Generalized Anxiety Disorder questionnaire GAD-7
Full Information
NCT ID
NCT02964598
First Posted
November 9, 2016
Last Updated
November 11, 2016
Sponsor
University of Helsinki
Collaborators
Academy of Finland
1. Study Identification
Unique Protocol Identification Number
NCT02964598
Brief Title
SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
Acronym
SleepHel
Official Title
Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Academy of Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type
Keywords
Adolescent, Population-based, Social jetlag, Intervention, Bright light, Motivation, Circadian regulation, Behavioral change
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Minimal information on sleep timing
Arm Title
Psychoeducation
Arm Type
Experimental
Arm Description
An extensive psychoeducational platform
Arm Title
Bright light
Arm Type
Experimental
Arm Description
Bright light treatment with 10 000 lux at max
Arm Title
Gamified intervention
Arm Type
Experimental
Arm Description
A new gamified intervention designed for mobile phones
Arm Title
Bright light and gamified intervention
Arm Type
Experimental
Arm Description
A combination of the two
Arm Title
Sleep coaching
Arm Type
Experimental
Arm Description
A new intervention protocol including a personified approach to solve problems and increase motivation for better sleep behavior
Arm Title
Sleep coaching + bright light
Arm Type
Experimental
Arm Description
A combination of the two
Intervention Type
Behavioral
Intervention Name(s)
Gamified intervention
Other Intervention Name(s)
Helsinki Sleep Factory
Intervention Description
A new mobile application for assisting in sleep regulation, duration 4-6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Sleep coaching
Intervention Description
A new personalized program, duration 4-6 weeks
Intervention Type
Device
Intervention Name(s)
Bright light
Intervention Description
Morning bright light 10 000 lux maximum duration 4-6 weeks
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Minimal information on sleep timing and advancing the sleep rhythm
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
An extensive information platform in the internet created for this purpose
Primary Outcome Measure Information:
Title
Circadian sleep rhythm
Description
Actigraphy (brand GeneActiv)
Time Frame
8 weeks
Title
Circadian body temperature rhythm
Description
iButton measurement from the wrist
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mood
Description
Experience sampling method, brand Psymate
Time Frame
8 weeks
Title
Insomnia symptoms
Description
Bergen Insomnia Scale
Time Frame
8 weeks
Title
Sleep problems
Description
Pittsburgh Sleep Quality Index
Time Frame
8 weeks
Title
Depression
Description
Beck Depression Inventory
Time Frame
8 weeks
Title
Anxiety
Description
Generalized Anxiety Disorder questionnaire GAD-7
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu-Katriina Pesonen, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Helsinki
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE
We'll reach out to this number within 24 hrs