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临床试验/NCT06975709
NCT06975709招募中不适用

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Primary Outcome

研究概览

简要总结

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

详细描述

Temporomandibular disorders (TMD) are complex conditions, which can have a significant impact on patients' health and quality of life. Furthermore, they are unclearly associated with sleep disorders. The aim of the study is to investigate the prevalence of TMD in patients with sleep disorders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age >18 years
  • Famale and Male
  • Signature of the privacy information form
  • Signature of the informed consent form of the protocol
  • Subjects capable of understanding and wanting
  • Subjects suffering from a sleep disorder (Insomnia,Hypersomnia,Restless legs syndrome,REM sleep behavior disorder,Narcolepsy,Obstructive sleep apnea syndrome (OSAS),Primary snoring, REM parasomnias,Nocturnal epilepsy)

排除标准

  • Physical trauma to the head and neck area
  • Painful oral pathologies (e.g. pulpitis, tooth fractures, tooth abscesses, tooth decay, canker sores and mucosal wounds)
  • Recent dental treatments that may cause pain (e.g. tooth extraction, tooth root canal)
  • Use of oral contraceptives
  • Subjects not capable of understanding and wanting
  • Patients suffering from neurological pathologies that may interfere with the completion of the questionnaires (ES dementia) or psychiatric pathologies or drug use as per DSM-5 criteria (including schizophrenia, bipolar, major depression, substance abuse, personality disorders).

结局指标

主要结局

Primary Outcome

时间窗: at enrollment

The main aim of the present study is to evaluate the prevalence of TMDs in patients with sleep disorders. This population was selected in order to contribute, in the context of scientific research, to the investigation into the association between temporomandibular disorders and sleep disorders, which include all those disorders that compromise both the quantity and quality of sleep with repercussions important on general health and quality of life, like: * Insomnia * Hypersomnia * Restless legs syndrome * REM sleep behavior disorder * Narcolepsy * Obstructive sleep apnea syndrome (OSAS) * Primary snoring * REM parasomnias (Sleepwalking, arousal disorders, excessive daytime sleepiness and night terrors) * Nocturnal epilepsy Patients with sleep disorders may be recruited in the observational study conducted by the University's Department of Dentistry Vita-Salute San Raffaele and the Neurology-sleep disorders unit of the San Raffaele Hospital in Turro, aimed at evaluating the prevalence of T

次要结局

  • Secondary Outcome(at enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Ferini Strambi

Prof

IRCCS San Raffaele

研究点 (2)

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