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

NCT07433491 | Not Yet Recruiting

• 4 other identifiers: 6130-6130F-12812593439764677
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Insomnia; Delayed Sleep Phase Disorder; Hyperarousal; Transdiagnostic Psychopathology; Child and Adolescent Psychiatry

Keywords

children; adolescents; child and adolescent psychiatry; insomnia; delayed sleep phase disorder; hyperarousal; sleep; hospital ward; outpatients; Blue-blocking glasses; virtual dark therapy; blue-blocking interventention; mobile-phone; screen; actigraphy; 6-sulfatoxymelatonin; Heart Rate Variability; light; activation; melatonin; inpatients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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 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.

• 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.

• KID-SCREEN-10

  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)

  From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.

Study Arms (2)

Blue-blocking glasses

EXPERIMENTAL

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

Dark mode (mobile phone)

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Virtual darkness, Orange glasses, Amber lenses, Blue-blocking light filters

Blue-blocking glasses

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

Also known as: Dark mode, Night mode

Dark mode (mobile phone)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Helse Fonna: lead
• University of Bergen: collaborator
• University of Oslo: collaborator
• University Hospital of North Norway: collaborator
• Helse Vest: collaborator

Study Sites (2)

BUP Haugesund

Haugesund, Rogaland, 5520, Norway

Location

BUPA Tromsø, The University Hospital of North Norway

Tromsø, Troms, 9019, Norway

Location

Related Publications (4)

• 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.

  PMID: 27322730 BACKGROUND

• 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.

  PMID: 39642162 BACKGROUND

• 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.

  PMID: 31967375 BACKGROUND

• 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.

  PMID: 27226262 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Tone Elise G Henriksen, MD PhD

  Helse Fonna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tone Elise G Henriksen, MD PhD

CONTACT

004753473240; tgjo@helse-fonna.no

Marit Nymoen, PhD

CONTACT

0052732805; marit.nymoen@helse-fonna.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The persons performing the statistical analyses will be blinded for the group allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot RCT and feasibility study

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: IPD will be shared with other researchers upon reasonable request to the principal investigator.

Locations

NO (2)