Blue-blocking Glasses for Sleep Disorders in Child and Adolescent Psychiatry (BATCAT-pilot)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Transdiagnostic Psychopathology; Delayed Sleep Phase Disorder; Hyperarousal; Child and Adolescent Psychiatry
• Intervention / Treatment: Device: Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone; Other: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tone Elise G Henriksen, MD PhD; Phone Number: 004753473240; Email: tgjo@helse-fonna.no
• Study Contact Backup: Name: Marit Nymoen, PhD; Phone Number: 0052732805; Email: marit.nymoen@helse-fonna.no

Study Locations

• Norway
  • Rogaland
    • Haugesund, Rogaland, Norway, 5520
      • BUP Haugesund
      • Contact: Sigrund Drivenes, MSc; Phone Number: 004752732805; Email: sigrund.drivenes@helse-fonna.no
      • Contact: Georg W Reinhardt, MD; Phone Number: 004752732805; Email: georg.walter.reinhardt@helse-fonna.no
  • Troms
    • Tromsø, Troms, Norway, 9019
      • BUPA Tromsø, The University Hospital of North Norway
      • Contact: Christian Eckhoff, MD, PhD; Phone Number: +47 +47761700700; Email: christian.eckhoff@uit.no
      • Contact: Judeson Joseph, MD; Phone Number: +47 +4776170700; Email: judeson.joseph@unn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue-blocking glasses; Blue-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	Device: Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone; 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
Active Comparator: Dark mode (mobile phone); Application of dark mode setting on the participant's mobile phone (if not already in use) + registration of brightness on participants' mobile phone screen (%) + treatment as usual	Other: Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.
Change from baseline in overnight melatonin production at 1 week	Quantity of melatonin metabolite 6-sulphatoxymelatonin (aMT6s) in the total overnight urine volume (µg).	From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affektive Reactivity Index, relf reported (ARI-S)	Self-report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.	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 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.	From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention.
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.	From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
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.	From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.
Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ)	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").	From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.
Bergen Insomnia Scale (BIS)	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.	From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.
Motor activity	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)	From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
BioPoint biosensor	The BioPoint sensor is a physiological multisensor worn as a watch measuring heart rate, heart rate variability, peripheral skin impedance, peripheral temperature	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.
Affektive Reactivity Index, parent-reported (ARI-P)	Proxy (care-giver) report form for rating irritability, minimum value 7, maximum value 21, high score indicates worse outcome.	From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.

Collaborators and Investigators

• Sponsor: Helse Fonna
• Collaborators: University of Oslo; University Hospital of North Norway; University of Bergen; Helse Vest
• Investigators: Principal Investigator: Tone Elise G Henriksen, MD PhD, Helse Fonna

Publications and helpful links

General Publications

• Esaki Y, Kitajima T, Ito Y, Koike S, Nakao Y, Tsuchiya A, Hirose M, Iwata N. Wearing blue light-blocking glasses in the evening advances circadian rhythms in the patients with delayed sleep phase disorder: An open-label trial. Chronobiol Int. 2016;33(8):1037-44. doi: 10.1080/07420528.2016.1194289. Epub 2016 Jun 20.
• Kallestad H, Langsrud K, Simpson MR, Vestergaard CL, Vethe D, Kjorstad K, Faaland P, Lydersen S, Morken G, Ulsaker-Janke I, Saksvik SB, Scott J. Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled trial. PLoS Med. 2024 Dec 6;21(12):e1004380. doi: 10.1371/journal.pmed.1004380. eCollection 2024 Dec.
• Henriksen TEG, Gronli J, Assmus J, Fasmer OB, Schoeyen H, Leskauskaite I, Bjorke-Bertheussen J, Ytrehus K, Lund A. Blue-blocking glasses as additive treatment for mania: Effects on actigraphy-derived sleep parameters. J Sleep Res. 2020 Oct;29(5):e12984. doi: 10.1111/jsr.12984. Epub 2020 Jan 21.
• Henriksen TE, Skrede S, Fasmer OB, Schoeyen H, Leskauskaite I, Bjorke-Bertheussen J, Assmus J, Hamre B, Gronli J, Lund A. Blue-blocking glasses as additive treatment for mania: a randomized placebo-controlled trial. Bipolar Disord. 2016 May;18(3):221-32. doi: 10.1111/bdi.12390.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: sleep; melatonin; children; Heart Rate Variability; insomnia; adolescents; delayed sleep phase disorder; actigraphy; light; inpatients; screen; outpatients; hyperarousal; hospital ward; activation; Blue-blocking glasses; mobile-phone; child and adolescent psychiatry; virtual dark therapy; blue-blocking interventention; 6-sulfatoxymelatonin
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 6130-6130; F-12812 (Other Grant/Funding Number: Helse Vest Research Grant); 593439 (Other Identifier: Regional Committees for Medical and Health Research Ethics); 764677 (Other Identifier: SIKT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.
• IPD Sharing Access Criteria: IPD will be shared with other researchers upon reasonable request to the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No