Assessment of Light Therapy in Insomnia Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change Sleep latency
研究概览
简要总结
Sleep disorders represent a major public health issue and the leader in these disorders is insomnia with 10 to 15% of subjects in the general population reporting symptoms of insomnia with a daytime impact. In addition to being very common, insomnia leads to an increase in morbidity and mortality and weighs on healthcare systems worldwide. Despite this public health context, insomnia is underdiagnosed and rarely treated. Hypnotics have proven efficacy but with a risk of dependence and pharmacotolerance which appears within a few weeks. Cognitive behavioral therapy (CBT) has a good level of evidence and is now a benchmark treatment for the management of insomnia. Unfortunately, not all patients adhere to or respond to these procedures, which cannot be implemented for many of them either. There is therefore a need to identify other alternative therapeutic strategies, and we believe that exposure to light is a promising treatment.
In this perspective, it seems interesting to assess the effect of the propensity to fall asleep with an exposure to light therapy in patients suffering from insomnia.
In order to be in optimal ecological conditions, we want to use a portable light therapy device which allows easy, acceptable and ambulatory exposure.
If the lighttherapy is confirmed in insomnia under ecological conditions, this would make it possible to propose a new non-drug treatment, easy to access and on a large scale
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 30 to 60 years
- •Insomnia disorders (ICSD-3) with sleep latency >30min - 3 times a week
- •Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent
- •Patient affiliated to a social health insurance scheme
- •For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD).
排除标准
- •- Shift work in the year preceding inclusion
- •Trans meridian travel (> 2 time zones) in the month preceding inclusion
- •Patient in exclusion period determined by a previous or ongoing study
- •Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)
- •Patient under judicial protection
- •Patient under guardianship or curatorship
- •For a woman of childbearing age: ongoing pregnancy or breastfeeding
- •Drug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin.
- •Phase delay syndrome defined according to the criteria of the international classification of ICSD-3
- •Restless legs syndrome with IRLS score> 20
- •Other psychiatric disorders or addictive disorder (screening with the MINI structured interview)
- •Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion:
- •Chronic allergies
- •Neurological disorders
- •cardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseases
- •diseases of the immune system
- •kidney and urinary tract diseases
- •endocrine and metabolic diseases
- •infectious diseases
研究组 & 干预措施
Control
干预措施: Placebo with light therapy glasses (Other)
Light therapy
干预措施: light therapy with light therapy glasses (Other)
结局指标
主要结局
Change Sleep latency
时间窗: At day 0 and Day 44
Actimetry is used to compare the sleep latency
次要结局
- Change Circadian rythms(At day 0 and Day 90)
- Change Daytime sleepiness(At day 0 and Day 90)