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临床试验/NCT04633668
NCT04633668已完成不适用

Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias

University of Manitoba2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Nocturnal Activity

研究概览

简要总结

This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities).

详细描述

Sleep wake disorders are prevalent and impactful conditions often poorly assessed and sub-optimally treated in the clinical setting. Undiagnosed sleep disorders can masquerade as mental health conditions and worsen the outcomes associated with these conditions. Further, sleep disorders can develop from mental health conditions and the reverse is also true (particularly for mood disorders). Successful treatment of sleep disorders requires a targeted approach.

Parasomnias are unwanted physical or mental events that occur during sleep or during arousal from sleep. The states of wakefulness, NREM, and REM are normally distinct and occur in an organized and predictable pattern over the 24-hour period. However, in parasomnias, aspects of more than one state co-occur and intermix. There are four types of parasomnias identified by the Diagnostic and Statistical Manual of Mental Disorders ( DSM 5). These include two NREM parasomnias: sleepwalking and sleep terrors, and two REM parasomnias: nightmare disorder and REM sleep behaviour disorder (RSBD). Lifetime prevalence of these conditions ranges from 6.9% (sleepwalking) to 67% (nightmare disorder).

In general, NREM parasomnia events are primed by conditions that increase sleep pressure and triggered by sleep-disrupting factors. They are more likely to occur following sleep restriction or deprivation, when SWS rebounds. Immediate triggers of sleepwalking in adults are sleep disruptions associated with sleep-disordered breathing, periodic limb movements, noises and touch. Pilon et al. induced episodes in adult sleepwalkers, but not in non-sleepwalkers, with specific auditory stimuli and this effect was accentuated under conditions of prior sleep deprivation.

Currently accepted interventions for parasomnias include pharmacological and psychological treatments. Pharmacological interventions involve the use of sedating medications (benzodiazepines, tricyclic antidepressants) or alpha-1 blocker (Prazosin).

Cognitive Behavioral Therapy. Psychological treatments primarily rely on cognitive behavioral therapy to achieve better sleep hygiene, reduced hyperarousal, and to teach the ability to practice with reducing cognitive arousal during the sleep period through planned rehearsal and scheduled awakenings. There are no well elaborated and systematic treatment packages for Non-REM parasomnias and so this protocol will represent an innovation in this area. Therefore, the purpose of the study is to develop and test such a package.

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
Single (Participant)

盲法说明

Self-Monitoring of sleep

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM 5 Parasomnia Disorder
  • at least one parasomnia event per week
  • daytime fatigue or sleepiness
  • 6 months in duration

排除标准

  • current use of agents known to triggers parasomnias such as Lithium carbonate, Thioridazine, Chlorpromazine, Perhphenazine, Methaqualone, or Amitriptyline,
  • for participants taking benzodiazepines or Prazosin, a stable dose regime for the past 4 weeks,
  • excessive alcohol consumption defined as the consumption of > 10 alcoholic beverages per week

结局指标

主要结局

Nocturnal Activity

时间窗: 6 weeks

activity level during sleep period

Nightmares

时间窗: 6 weeks

Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares

Parasomnia events

时间窗: 6 weeks

# of parasomnia events

次要结局

  • Fatigue(6 weeks)
  • Depression, Anxiety, and Stress(6 weeks)
  • Insomnia(6 weeks)
  • Impairment(6 weeks)
  • Sleepiness(6 weeks)
  • Cognitive(6 weeks)

研究者

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

Dr. Nora Vincent

Psychologist/Professor

University of Manitoba

研究点 (2)

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