用于儿童和青少年精神科睡眠障碍的蓝光阻断眼镜 (BATCAT-pilot)
阻断蓝光眼镜治疗儿童青少年精神科晚间激活和睡眠障碍——一项跨诊断随机对照试验的初步研究。
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tone Elise G Henriksen, MD PhD
- 电话号码：004753473240
- 邮箱：tgjo@helse-fonna.no
研究联系人备份
- 姓名：Marit Nymoen, PhD
- 电话号码：0052732805
- 邮箱：marit.nymoen@helse-fonna.no
学习地点
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Rogaland
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Haugesund、Rogaland、挪威、5520
- 招聘中
- BUP Haugesund
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接触：
- Sigrund Drivenes, MSc
- 电话号码：004752732805
- 邮箱：sigrund.drivenes@helse-fonna.no
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接触：
- Georg W Reinhardt, MD
- 电话号码：004752732805
- 邮箱：georg.walter.reinhardt@helse-fonna.no
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Troms
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Tromsø、Troms、挪威、9019
- 尚未招聘
- BUPA Tromsø, The University Hospital of North Norway
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接触：
- Christian Eckhoff, MD, PhD
- 电话号码：+47 +47761700700
- 邮箱：christian.eckhoff@uit.no
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接触：
- Judeson Joseph, MD
- 电话号码：+47 +4776170700
- 邮箱：judeson.joseph@unn.no
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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 |
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
其他名称：
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有源比较器：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 |
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
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change form baseline in sleep onset latency (SOL) at 1 week
大体时间：From baseline to after 1 week of intervention. For outpatients, SOL is also measured after 2 weeks of intervention.
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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.
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Change from baseline in overnight melatonin production at 1 week
大体时间：From baseline after 1 week of intervention. For outpatients 6-sulphatoxymelatonin, is also analyzed after 2 weeks of intervention.
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Affektive Reactivity Index, relf reported (ARI-S)
大体时间：From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
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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.
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Self-report Generalized Anxiety Disorder -7 (GAD-7)
大体时间：From baseline to after 7 days of intervention. For outpatients, ARI-S and ARI-P are also assessed after 14 days of intervention.
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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.
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Patient Health Questionnaire (PHQ-9)
大体时间：From baseline to end of 7 days intervention. For outpatients, PHQ-9 is also assessed after 14 days of intervention.
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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.
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KID-SCREEN-10
大体时间：From baseline to end of 7 days intervention. For outpatients KIDSCREEN-10 is also assessed after 14 days of intervention.
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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.
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Reduced version Horne-Østberg Morningness Eveningess Questionnaire (r-MEQ)
大体时间：From baseline to after 7 days of intervention. For outpatients r-MEQ is also assessed after 14 days of intervention.
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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.
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Bergen Insomnia Scale (BIS)
大体时间：From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.
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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.
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Motor activity
大体时间：From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
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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)
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From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.
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BioPoint biosensor
大体时间：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.
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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.
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Affektive Reactivity Index, parent-reported (ARI-P)
大体时间：From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.
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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.
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合作者和调查者
赞助
调查人员
- 首席研究员：Tone Elise G Henriksen, MD PhD、Helse Fonna
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 6130-6130
- F-12812 (其他赠款/资助编号：Helse Vest Research Grant)
- 593439 (其他标识符：Regional Committees for Medical and Health Research Ethics)
- 764677 (其他标识符：SIKT)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data from GENEActiv, Biopoint and LYS-devices may be shared for IPD meta-analyses.
IPD 共享访问标准
IPD will be shared with other researchers upon reasonable request to the principal investigator.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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