SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE

Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type Clinical Trial

— SleepHel  

Official title:

Sleep Helsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02964598
• Other study ID #: 1287174
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 9, 2016
• Last updated: November 11, 2016
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Advisory Board on Research Integrity
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 270
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Behavioral:
• Gamified intervention
A new mobile application for assisting in sleep regulation, duration 4-6 weeks
• Sleep coaching
A new personalized program, duration 4-6 weeks

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

Other:
• Control
Minimal information on sleep timing and advancing the sleep rhythm
• Psychoeducation
An extensive information platform in the internet created for this purpose

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Academy of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian sleep rhythm	Actigraphy (brand GeneActiv)	8 weeks	No
Primary	Circadian body temperature rhythm	iButton measurement from the wrist	8 weeks	No
Secondary	Mood	Experience sampling method, brand Psymate	8 weeks	No
Secondary	Insomnia symptoms	Bergen Insomnia Scale	8 weeks	No
Secondary	Sleep problems	Pittsburgh Sleep Quality Index	8 weeks	No
Secondary	Depression	Beck Depression Inventory	8 weeks	No
Secondary	Anxiety	Generalized Anxiety Disorder questionnaire GAD-7	8 weeks	No