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临床试验/NCT05237778
NCT05237778已完成不适用

The Nightmare Catcher: Modulating Dreams With Targeted Memory Reactivation

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Nightmare Frequency Questionnaire (NFQ)

研究概览

简要总结

With this protocol, investigators examine whether targeted memory reactivation (TMR), a technique used to strengthen memories, can accelerate remission of nightmare disorder. This protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery Rehearsal Therapy (IRT), a recommended treatment of nightmares. Patients with nightmare disorder are asked to perform an initial IRT session and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound (TMR group), while no such pairing with a sound takes place for the other half (control group). During the next two weeks, all patients perform IRT every evening at home and are exposed to the sound during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the severity of nightmares before and after (2-weeks follow-up and 3-months follow-up) this intervention takes place using the validated Nightmare Frequency Questionnaire (NFQ, primary outcome measure), which retrospectively identifies the frequency of nightmares. We hypothesize that patients treated with IRT and who are exposed, during REM sleep and over 14 nights, to a sound that had previously been associated with the new positive dream scenario of IRT (TMR group), will have more reduced frequency of nightmares compared to participants with stimulation of the same, but non-associated, sound during REM sleep (control group).

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)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of nightmare disorder according to the International Classification of Sleep Disorders (ICSD-3) diagnostic and coding manual
  • •Patients with at least moderate severity (>1 episode per week)

排除标准

  • •severe depression
  • •insomnia disorder
  • •psychosis or anxiety disorder
  • •other sleep disorder (e.g.,obstructive sleep apnea syndrome, restless legs syndrome)
  • •neurological disease
  • •use of medications that would be likely to produce nightmares (e.g. hypnotics, β-blockers, amphetamines, antimicrobial agents)
  • •use of anxiolytics, antipsychotic or antidepressant medication were excluded.

研究组 & 干预措施

TMR group

Experimental

Patients will receive a sound while they generate a positive outcome of imagery rehearsal therapy (IRT). They will also receive the sound during REM sleep.

干预措施: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep (Behavioral)

Control group

Active Comparator

Patients will not receive a sound while they generate a positive outcome of imagery rehearsal therapy (IRT). They will receive the same sound as the experimental group during REM sleep under the same conditions.

干预措施: Imagery Rehearsal Therapy (Behavioral)

结局指标

主要结局

Nightmare Frequency Questionnaire (NFQ)

时间窗: 3 months

Validated self-report scale to assess the number of nightmares per week

Nightmare Frequency Questionnaire (NFQ)

时间窗: 2 weeks

Validated self-report scale to assess the number of nightmares per week

次要结局

  • Beck Depression Inventory (BDI-II)(3 months)
  • Nightmare Distress Questionnaire (NDQ)(3 months)
  • Pittsburgh Sleep Quality Index (PSQI)(3 months)
  • Proportion of the emotion 'fear' in dreams(2 weeks)
  • Proportion of the emotion 'joy' in dreams(2 weeks)
  • Nightmare Distress Questionnaire (NDQ)(2 weeks)
  • Beck Depression Inventory (BDI-II)(2 weeks)
  • Pittsburgh Sleep Quality Index (PSQI)(2 weeks)

研究者

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

Lampros Perogamvros

Senior Clinical Fellow

University Hospital, Geneva

研究点 (1)

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