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Blåblockerande glasögon för sömnstörningar inom barn- och ungdomspsykiatri (BATCAT-pilot)

17 september 2026 uppdaterad av: Helse Fonna

Blåblockerande glasögon för behandling av kvällsaktivering och sömnstörningar inom barn- och ungdomspsykiatri - en pilotstudie med transdiagnostisk randomiserad kontrollerad prövning.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Enhet: 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

Andra namn:
  • Virtuell mörker
  • Orangeglasögon
  • Amberlinser
  • Blåblockerande ljusfilter
Aktiv komparator: 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
Övrig: 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

Andra namn:
  • Mörkt läge
  • Nattläge

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change form baseline in sleep onset latency (SOL) at 1 week
Tidsram: 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.
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
Tidsram: 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).
From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Affektive Reactivity Index, relf reported (ARI-S)
Tidsram: 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.
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)
Tidsram: 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.
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)
Tidsram: 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.
From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
KID-SCREEN-10
Tidsram: 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.
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)
Tidsram: 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").
From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.
Bergen Insomnia Scale (BIS)
Tidsram: 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.
From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.
Motor activity
Tidsram: 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)
From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
BioPoint biosensor
Tidsram: 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
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)
Tidsram: 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.
From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Helse Fonna

Samarbetspartners

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

Utredare

  • Huvudutredare: Tone Elise G Henriksen, MD PhD, Helse Fonna

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

7 januari 2026

Först inskickad som uppfyllde QC-kriterierna

24 februari 2026

Första postat (Faktisk)

25 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 september 2026

Senast verifierad

1 mars 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 6130-6130
  • F-12812 (Annat bidrag/finansieringsnummer: Helse Vest Research Grant)
  • 593439 (Annan identifierare: Regional Committees for Medical and Health Research Ethics)
  • 764677 (Annan identifierare: SIKT)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.

Kriterier för IPD Sharing Access

IPD will be shared with other researchers upon reasonable request to the principal investigator.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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