About this trial
Sleep problems and regulation difficulties are frequent in the child and adolescent psychiatry population. Insomnia and delayed sleep-wake phase disorders (DSPWD) are highly prevalent, and risk factors for developing more severe illness courses and chronic disorders. Pharmacological treatments of sleep disorders dominate even for the youngest patients but are unsupported by long-term data on outcome and side effects. The majority of non-pharmacological treatment options are composite and resource demanding. The investigators will examine the effects and feasibility of the isolated intervention of evening/night use of blue-blocking glasses/real darkness as adjunctive treatment for insomnia and delayed sleep phase disorder in inpatient and outpatient settings for children and adolecents.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 12-18 years, receiving health-care from child and adolescent mental health services at UPA University Hospital of North Norway, Tromsø or BUP Haugesund Hospital, Haugesund
Current Insomnia or DSPD comorbid to one or several pychiatric symptom presentations or diagnoses
Able and willing to provide written informed consent
Participants aged 12-15,9 years also need consent from both parents/carers
Disqualifiers
Not able to comply with protocol for a required minimum of one night
Blindness or severely reduced translucency of both eyes
Known malformation or damage of optical tract blindness
Use of melatonin all formulas that cannot be paused
Trial design
Parallel
Treatments tested in this trial
Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone
DeviceBlue-blocking glasses and night mode on mobile phoneBlue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participant's mobile phone screen (%) + treatment as usual
Control
Other interventionApplication of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on particpants's mobile phone screen (%) + Treatment as usual
Treatment groups
Trial outcomes
Primary outcomes
Change form baseline in sleep onset latency (SOL) at 1 week
Sleep onset latency (minutes) subjectively assessed in sleep diary and objectively assessed from actigraphy derived sleep parameters. Sleep onset latency describes how long it takes to fall asleep from the moment the person tries to fall asleep to sleep starts.
Change from baseline in overnight melatonin production at 1 week
Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg).
Secondary outcomes
Affektive Reactivity Index, relf reported (ARI-S)
Self-report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.
Self-report Generalized Anxiety Disorder -7 (GAD-7)
GAD-7 is 7- item self-report questionnaire used for rating general symptoms of anxiety, minimum value 7, maximum value 28, high score indicates worse outcome.
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a nine-item self-report questionnaire rating depressive symptoms, minimum value 9, maximum value 36, high score indicate worse outcome.
KID-SCREEN-10
The KID-SCREEN 10 is self report instrument for assessing quality of life for children and adolescents, minimum value 10, maxium value 50, high score indicates better outcome.
Sponsors and contacts
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Helse Fonna
Lead sponsor
University of Bergen
Collaborator
University of Oslo
Collaborator
University Hospital of North Norway
Collaborator
Helse Vest
Collaborator