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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Другое 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

Первичные конечные точки

• Change form baseline in sleep onset latency (SOL) at 1 week [Срок оценки: 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 [Срок оценки: From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Норвегия · 2 центра

• BUP Haugesund — Haugesund
• BUPA Tromsø, The University Hospital of North Norway — Tromsø

Публикации

• 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
• 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.10043 PMID 39642162
• 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
• 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

Идентификаторы

NCT: NCT07433491 · 6130-6130 · F-12812 · 593439 · 764677

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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