Blue-blocking Glasses for Treating Evening Activation and Sleep Disorders in Child and Adolescent Psychiatry - a Pilot Trans-diagnostic Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change form baseline in sleep onset latency (SOL) at 1 week
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The persons performing the statistical analyses will be blinded for the group allocation of the participants.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Blue-blocking glasses (BB-glasses) or real darkness from 9 p.m. to desired wake-up time + night mode setting on mobile phone (Device)
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
干预措施: Control (Other)
结局指标
主要结局
Change form baseline in sleep onset latency (SOL) at 1 week
时间窗: 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.
Change from baseline in overnight melatonin production at 1 week
时间窗: 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).
次要结局
- 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.)
- Bergen Insomnia Scale (BIS)(From baseline to after 7 days of intervention. For outpatients, BIS is also assessed after 14 days of intervention.)
- Motor activity(From baseline to after 7 days of intervention. For outpatients, parameters are also assessed after 14 days of intervention.)
- BioPoint biosensor(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)(From baseline to after 7 days of intervention. For outpatients ARI-S and ARI-P are also assessed after 14 days of intervention.)