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Trial registered on ANZCTR


Registration number
ACTRN12614000308695
Ethics application status
Approved
Date submitted
18/03/2014
Date registered
24/03/2014
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Delayed Sleep Phase Disorder in Adolescents and Young Adults
Scientific title
The effect of morning bright light therapy and activity on sleep, daytime functioning and cognitive performance in adolescents and young adults with Delayed Sleep Phase Disorder.
Secondary ID [1] 284268 0
Nil
Universal Trial Number (UTN)
U1111-1154-5351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Sleep Phase Disorder 291393 0
Condition category
Condition code
Mental Health 291755 291755 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive morning bright light therapy using Re-timer glasses, a common treatment for Delayed Sleep Phase Disorder. Re-timer is a light device, worn just like a pair of glasses that produces a 100% UV-free light, which helps your body recognise when to be awake and when to sleep. Following basic sleep education, participants will be instructed to advance their wake up time by half an hour each day and wear the Re-timer bright light glasses for 30 minutes immediately after rising from bed.
1) Green Bright Light: Participants will follow instructions regarding their sleep timing (as explained above) and undergo morning bright light therapy with green wavelength light.
2) Green Bright Light plus Exercise: Participants will follow instructions regarding their sleep timing, undergo morning bright light therapy with green wavelength light and complete 30 minutes of exercise immediately after rising from bed each morning, (whilst wearing the Re-timer glasses), by playing a motion sensing video game.
3) Red Bright Light: Participants will follow instructions regarding their sleep timing (as explained above) and undergo morning bright light therapy with red wavelength light.
4) Red Bright Light plus Exercise: Participants will follow instructions regarding their sleep timing, undergo morning bright light therapy with red wavelength light and complete 30 minutes of exercise immediately after rising from bed each morning, (whilst wearing the Re-timer glasses), by playing a motion sensing video game.
Participants attend three treatment sessions in total, which will be administered by a Psychologist, Clinical Psychologist or Provisional Psychologist. Each of the 3 treatment sessions are one week apart (e.g., 21 days of treatment) and will last approximately 1.5 hours each time. Treatment will involve basic sleep education regarding normal sleep and the circadian rhythm, as well as individualised behavioural instructions, including how and when to use the Re-timer glasses, when to avoid bright light in the evening, and in the exercise conditions, the duration, intensity and type of exercise prescribed. Behavioural instructions will differ for each participant, depending on the severity of sleep timing delay and desired bed and wake up times. Participants will advance their wake up time by half an hour each day until their desired wake up time is achieved (usually no earlier than 6am). Therefore, the number of days spent advancing sleep timing will depend upon participant’s natural wake up time and their desired wake up time. For example, someone waking at noon, who wishes to wake at 7am, may require 10 days of advancement. Whereas, someone waking at 10am, who wishes to wake at 8am may only require 4 days of advancement. Following sleep timing advancement, participants will undergo a period of consolidation, to maintain their desired sleep schedule, for the remainder of the treatment period.
Adherence to the interventions will be assessed daily, by self- and parent-report on the sleep diary (e.g., how long did you wear the Re-timer glasses/ exercise for this morning in minutes?). As an additional objective measure of sleep timing and activity levels, actigraphic data will be collected.
Intervention code [1] 288976 0
Treatment: Devices
Intervention code [2] 288977 0
Behaviour
Comparator / control treatment
Within this design, the two treatment conditions receiving Red Bright Light therapy (Red Bright Light, Red Bright Light plus Exercise) will serve as comparator groups. Although there is recent empirical evidence indicating that red bright light can lead to improvements in sleep and daytime functioning, green wavelength light had been found to be more effective at phase advancing the circadian rhythm.
Control group
Active

Outcomes
Primary outcome [1] 291691 0
Sleep Parameters from Sleep Diary: bed time, rise time, sleep onset latency, total sleep time.
Timepoint [1] 291691 0
Pre-treatment, Treatment Session 1,2 and 3, 1-month follow-up, 3-month follow-up.
Secondary outcome [1] 307292 0
Daytime Functioning: daytime sleepiness, fatigue, mood and feelings, sleep anticipatory anxiety and insomnia symptoms.
Measures include the Paediatric Daytime Sleepiness Scale (PDSS), Flinders Fatigue Scale (FFS), short Mood and Feelings Questionnaire (MFQ), Sleep Anticipatory Anxiety Questionnaire (SAAQ), Insomnia Severity Index (ISI), Sheehan Disability Scale.
Timepoint [1] 307292 0
Pre-treatment, Treatment Session 1,2 and 3, 1-month follow-up, 3-month follow-up.
Secondary outcome [2] 307323 0
Cognitive Functioning: Working memory/Processing Speed and Executive Functioning.
Measure include: Digit Symbol, Letter Numbering Sequencing and Symbol Search tests, Colour Word Inference test and Verbal Fluency test.
Timepoint [2] 307323 0
Pre-treatment, Post-treatment, 6-month Follow Up.

Eligibility
Key inclusion criteria
Meet diagnostic criteria for Delayed Sleep Phase Disorder according to the International Classification of Sleep Disorders-2 manual.
Minimum age
13 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atypical development, English as a second language, sleep disorders of a differential diagnosis (e.g., sleep disordered breathing, parasomnias)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once diagnosed via clinical sleep history interview, participants randomly assigned via computerised random allocation system, using blocks. The sequence will be predetermined before participants diagnosis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Linear Mixed Model Regressions will be used for statistical analysis. Although an effect size between green light + exercise vs green light no exercise has not previously been determined, based on a conservative estimate of a small effect size, with a statistical power of 0.80, and an alpha level of 0.05, the minimum sample size is 76. Our previous trial comparing combined light therapy + psychological therapy vs control showed large effects. Based on these, we estimate a minimum sample size of 36 needed to observe effect between the light and activity conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288900 0
University
Name [1] 288900 0
Flinders University
Address [1] 288900 0
GPO Box 2100
Adelaide SA 5001
Country [1] 288900 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Michael Gradisar
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 287594 0
None
Name [1] 287594 0
Address [1] 287594 0
Country [1] 287594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290730 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290730 0
Ethics committee country [1] 290730 0
Australia
Date submitted for ethics approval [1] 290730 0
25/04/2014
Approval date [1] 290730 0
19/06/2014
Ethics approval number [1] 290730 0

Summary
Brief summary
This study aims to evaluate the efficacy of morning bright light therapy for adolescents with Delayed Sleep Phase Disorder, using newly developed portable LED glasses technology. The study also aims to investigate whether morning activity influences adolescents sleep, daytime functioning and cognitive performance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46958 0
A/Prof Michael Gradisar
Address 46958 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 46958 0
Australia
Phone 46958 0
+61882012192
Fax 46958 0
+61 8 82013877
Email 46958 0
michael.gradisar@flinders.edu.au
Contact person for public queries
Name 46959 0
Miss Cele Richardson
Address 46959 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 46959 0
Australia
Phone 46959 0
+61882015122
Fax 46959 0
+61 8 82013877
Email 46959 0
rich0413@flinders.edu.au
Contact person for scientific queries
Name 46960 0
Miss Cele Richardson
Address 46960 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 46960 0
Australia
Phone 46960 0
+61882015122
Fax 46960 0
Email 46960 0
rich0413@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary