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NCT Number: NCT07433491

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

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.

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Key information

Conditions

Insomnia Child and Adolescent Psychiatry Delayed Sleep Phase Disorder Dyssomnias Hyperarousal Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Transdiagnostic Psychopathology

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BUP Haugesund, Haugesund, Rogaland, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone

Device

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

Other names: Virtual darkness, Orange glasses, Amber lenses, Blue-blocking light filters

Control

Other

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

Other names: Dark mode, Night mode

Primary outcomes

  1. Change form baseline in sleep onset latency (SOL) at 1 week

    Time frame: 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.

  2. Change from baseline in overnight melatonin production at 1 week

    Time frame: 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

  1. Affektive Reactivity Index, relf reported (ARI-S)

    Time frame: 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.

  2. Self-report Generalized Anxiety Disorder -7 (GAD-7)

    Time frame: 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.

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  4. KID-SCREEN-10

    Time frame: 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.

  5. Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ)

    Time frame: 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").

  6. Bergen Insomnia Scale (BIS)

    Time frame: 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.

  7. Motor activity

    Time frame: 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)

  8. BioPoint biosensor

    Time frame: 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

  9. Affektive Reactivity Index, parent-reported (ARI-P)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marit Nymoen, PhD

CONTACT

[email protected]

0052732805

Tone Elise G Henriksen, MD PhD

CONTACT

[email protected]

004753473240

Sponsors and collaborators

Lead sponsor

Helse Fonna

Other

Collaborators

  • Helse Vest
  • University Hospital of North Norway
  • University of Bergen
  • University of Oslo

Registry information

Official study title

Blue-blocking Glasses for Treating Evening Activation and Sleep Disorders in Child and Adolescent Psychiatry - a Pilot Trans-diagnostic Randomized Controlled Trial.

Acronym: BATCAT-pilot

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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