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临床试验/NCT03167801
NCT03167801已完成不适用

Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients

Centre d'Investigation Clinique et Technologique 8051 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Urinary 6-sulfatoxy-melatonin (U6SM)

研究概览

简要总结

To evaluate the relationship between secretion of melatonin and sleep quality in spinal cord injury patients versus a database of healthy volunteers.

详细描述

Melatonin is a neurohormone secreted by the pineal gland and excreted by the urinary tract. It has a key role in the synchronisation of circadian rhythms including the sleep wake cycle, with a peak secretion around 03:00.

The neural pathway controlling melatonin secretion is long and transits via the thoracic spine. The exact level is not known, but interruption of the connection in patients with lesions of the spinal cord is known to occur.

Tetraplegic patients often complain of insomnia, daytime sleepiness and poor sleep quality but the contribution of melatonin levels to sleep quality has not been explored in large studies, although case reports have shown reduced or abolished melatonin secretion and altered melatonin secretion profiles with delayed peak secretion. Paraplegic patients report fewer sleep difficulties and little is known about melatonin secretion in this group. The investigators hypothesize that sleep abnormalities are related to abnormalities in melatonin secretion and that this is in turn related to the level of the spinal cord injury

The study aims to explore the profiles of melatonin secretion in patients with spinal cord injuries and comparing melatonin profiles with a database of healthy volunteers. The investigators will further analyse the results looking at the severity of spinal cord injury using the Abbreviated Injury Scale (AIS) and the level of the injury. Outcome measures are melatonin secretion profile, sleep complaints measured using the Pittsburgh scale and daytime sleepiness measured using the Epworth sleep scale.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female ≥ 18 years
  • Spinal cord injury patient
  • All score AIS
  • With a chronic lesion (more than 6 months from initial injury)
  • Signed informed consent

排除标准

  • Pregnant women
  • Breast feeding women
  • Refusal to participate at study
  • Not covered by national health insurance scheme
  • Patient unable to give informed consent
  • Transmeridian flight crossing more than 3 time zones in the month preceding the study
  • Recent treatment with melatonin (< 1 month) or beta blocker

结局指标

主要结局

Urinary 6-sulfatoxy-melatonin (U6SM)

时间窗: 24 hours

Urinary 6-sulfatoxy-melatonin (U6SM) will be measured during 24 hours

次要结局

  • Sleep quality(24 hours)
  • Daytime sleepiness(24 hours)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (1)

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