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临床试验/NCT02906904
NCT02906904撤回不适用

Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia

University Hospital, Montpellier1 个研究点 分布在 1 个国家开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.

研究概览

简要总结

Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias.

The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness.

Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses.

The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subject from 18 years-old to 45 years-old
  • Affiliated to social security
  • Written informed consent
  • * CASE specific inclusion criteria :
  • NREM parasomnia diagnosed according to the International Classification of Sleep Disorders 3rd edition (ICSD-3) criteria and confirmed by polysomnography assessment
  • Frequent symptomatology (at least 1 episode by week in the past 3 months)
  • * CONTROL specific inclusion criteria :
  • No medical history of NREM parasomnia

排除标准

  • Known skin allergy to metal
  • Use of psychotropic drugs during the 15 days before the inclusion
  • Use of analgesic drugs during the 15 days before the inclusion
  • A diagnosis of sleep apnea syndrome, periodic limb movements or restless legs syndrome present more than twice a week
  • Medical history of epilepsy
  • Non stable psychiatric disorder
  • Pregnancy, breastfeeding
  • Subject deprived of liberty or protected by law (tutorship, curatorship).

研究组 & 干预措施

CASE (adult sleepwalking patients)

Experimental

干预措施: Case Intervention (Other)

CONTROL (adult healthy volunteers)

Experimental

干预措施: Control Intervention (Other)

结局指标

主要结局

Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.

时间窗: within 5 seconds after stimulation

次要结局

  • Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale(on inclusion)
  • Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2(within 5 seconds)
  • Nociceptive behavioural response(within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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