Randomized Open-label Trial Evaluating Light Therapy on Sleep Quality in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Impact of light therapy on the quality of sleep of dialysis patients
研究概览
简要总结
Sleep disorders are common in dialysis patients. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.
Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin.
Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.
详细描述
Sleep disorders are common in dialysis patients. Indeed, several studies have reported that the prevalence of these disorders is higher than that of the general population. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.
Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin. Light therapy has been studied in several pathologies. In the context of renal insufficiency, only one randomized study was conducted in renal transplant patients: out of 30 patients, the effect of light therapy regained an 11-minute increase in sleep latency, an earlier awakening of 24 minutes, and a gain in the DASS-21 depression score of 1.7 points while there was no improvement in his three parameters in the control group. Interest in light therapy has also been evaluated in seasonal and non-seasonal depression. In a meta-analysis of 458 patients, light therapy adjuvant use was as effective as the addition of a second molecule.
Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.
We therefore wish to set up a clinical study to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients. The secondary objectives will be to specify the improved sleep parameters, to evaluate the impact on the anxious-depressive score, the arterial hypertension, and the nutritional state, and the residual effect of light therapy.
The aim of this trial is to determine whether a light therapy technique in the morning during dialysis or at home improves the quality of sleep of chronic hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in conventional hemodialysis or hemodiafiltration for at least 3 months
- •Patient requiring a dialysis session three times a week in the investigational site
- •Patient benefiting from a social security scheme
- •Patient informed and having given his free and informed consent to participate in the study
排除标准
- •Patient with binocular blindness and / or age-related macular degeneration
- •Eye fatigue
- •Patient who has undergone a recent eye surgery (less than 3 months) or for whom such an operation is planned in the next 20 weeks
- •Patient taking medications known to be responsible for photosensitivity
- •Pregnant or lactating woman
- •Patient under guardianship or curatorship
- •Patient unable to give free and informed consent
- •Exclusion during the study - premature stop
- •Wishes of the patient or the physician
- •Appearance of unexplained visual disturbances
- •Kidney transplant
结局指标
主要结局
Impact of light therapy on the quality of sleep of dialysis patients
时间窗: 5 weeks
The Pittsburgh Sleep Quality Index (PSQI) questionnaire is a self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. The primary endpoint is the measured difference in PSQI score between baseline and 5 weeks post-exposure to light therapy between the two arms of the study (no light therapy versus active light therapy).
次要结局
- Analysis of each component of the PSQI score(5 weeks)
- Pathological sleep disorders defined by PSQI score > 5(5 weeks)
- Anxious-depressive state of the patients(5 weeks)
- Impact of light therapy on nutritional intake of patients(10 weeks)
- Systolic Blood Pressure values(10 weeks)
- Side effects of light therapy(5 weeks)
- Diastolic Blood Pressure values(10 weeks)
- Evaluation of the residual duration of the effect of light therapy on sleep disorder(5 weeks)
- Evaluation of the residual duration of the effect of light therapy on anxious-depressive state of the patients(5 weeks)
- Impact of home care on the effectiveness of the primary endpoint(5 weeks)