Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry

The investigators will conduct a pilot study to examine the effect and feasibility of blue-blocking glasses as adjunctive treatment for insomnia and delayed sleep phase disorder in child and adolescent inpatients and outpatient settings. If the intervention and protocol are feasible and promising with regards to clinical and physiological effects, the study will provide a sound base for planning larger multicenter RCT's. Blue-blocking glasses are a minimal risk, low-cost intervention, and have potential to improve illness-course through improved sleep and healthier circadian function. The intervention may reduce the need for pharmacological treatment for sleep and circadian disorders and enhance coping strategies for the adolescents and their caregivers. Lastly, the pilot study will yield much needed data on light conditions (daylight and nightlight) in hospital environments for children and adolescents and may contribute to improved sleep conditions in hospital wards.

• Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone (Device), also known as Virtual darkness, Orange glasses, Amber lenses, Blue-blocking light filters: Blue-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), also known as Dark mode, Night mode: Application 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

Primary outcomes

• Change form baseline in sleep onset latency (SOL) at 1 week [From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.]: 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 [From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.]: Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg).

Secondary outcomes

• Affektive Reactivity Index, relf reported (ARI-S) [From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.]: 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) [From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention.]: 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) [From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.]: 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 [From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.]: 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.
• Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ) [From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.]: The r-MEQ is a self report questionnaire for assessing morning or evening preference of the sleep/wake cycle, minimum value 4, maximum value 25, high score indicates morning type ("lark"), low score indicates evening type ("owl").
• Bergen Insomnia Scale (BIS) [From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.]: BIS is a self report questionnaire for diagnostic support (insomnia) and as a contiunous outcome variable. We will use BIS in the inclusion procedure but also repeat it as a subjective outcome measure of sleep problems and daytime function. Minimum value 0, maksimum value 42, high score indicate worse outcome.
• Motor activity [From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.]: GENEActive wristworn actigraph with RGB light sensor, (Active Insights, Manchester, UK). Motor activity/motor activity derived sleep outcomes (other than primary outcome) include: Total sleep time (sleep diary, actigraphy) * Wake after sleep onset * Motor activity in sleep interval * Sleep efficency * Sleep onset * Sleep offset * Mid-sleep time * Motor activity patterns (circadian, motor variabilty, complexity)
• BioPoint biosensor [During first and 7th day of intervention (inpatients), during 7th and 14 days of intervention (outpatients) For all patients the outcomes will be compared to baseline assessments.]: The BioPoint sensor is a physiological multisensor worn as a watch measuring heart rate, heart rate variability, peripheral skin impedance, peripheral temperature
• Affektive Reactivity Index, parent-reported (ARI-P) [From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.]: Proxy (care-giver) report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.

Sex: All, ages: 12 Years to 18 Years

Inclusion Criteria:

* 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
* Able to comply with protocol
* Able to discontinue melatonin or BB-glasses if currently used, with at least 3 days washout period

Exclusion Criteria:

* 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
* High risk for suicide or self-harm
* Consent from both partents/carers unlikely (participants age 12-15,9 years)

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• Tone Elise G Henriksen, MD PhD, Principal investigator, Helse Fonna