Neural Responses and Connectivity During Rest, Memory Encoding and Emotional Stimulation in Chronic Insomnia, and Their Relationships With Insomnia Treatment: a Wait-list Controlled Randomized Trial of Cognitive-behavioural Therapy for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Functional magnetic resonance imaging (fMRI) to examine brain responses to working memory with increasing task difficulty
研究概览
简要总结
Individuals with chronic insomnia have persistent difficulty falling and staying asleep, as well as complaints of altered daytime functioning that may be associated with cognitive impairments. The neural processes underlying these daytime complaints may involve abnormal activation of brain regions and neural networks involved in working memory, memory encoding and emotions. The goal of this study is to assess whether a psychological treatment for insomnia will reverse these abnormalities in brain responses to cognitive tasks and at rest. A secondary objective of the study is to characterize impairments in attentional processing and assess if the impairments can be reversed by the psychological treatment. We hypothesized that the psychological treatment for insomnia will lead to a normalization of the brain responses to working memory, declarative memory encoding, insomnia-related stimuli, and the functional connectivity within the default-mode and limbic networks.
详细描述
Study hypothesis
Brain responses associated with working memory task and declarative memory encoding will be decreased in chronic insomnia compared to good sleepers and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger recovery in these brain responses, compared to a 3-month wait period.
Brain responses to emotional stimulation, especially to insomnia-related stimuli, will be increased in chronic insomnia compared to good sleepers, and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger reduction in these brain responses, compared to a 3-month wait period.
Connectivity in the default-mode and limbic networks during resting-state will be increased in chronic insomnia compared to good sleepers, and, among individuals with chronic insomnia, cognitive-behavioral therapy for insomnia will lead to larger reduction in this connectivity, compared to a 3-month wait period.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •80 participants with chronic primary insomnia (40 per group) 40 good sleepers
排除标准
- •Older than 65 y.o. or younger than 25 y.o.
- •Contraindication to the MRI scanning
- •Current neurological disorder
- •Past history of brain lesion
- •Major surgery (i.e., requiring general anesthesia) in the past 3 months
- •Untreated thyroid disorder
- •Chronic pain syndrome self-reported as interfering with sleep
- •Recent and severe infection in the past 3 months
- •Active cancer, or remitted cancer with cancer treatment within the last 2 years
- •Myocardial infarct
- •Arterial bypass or angioplasty
- •Heart failure causing limitation of ordinary physical activity
- •Renal insufficiency
- •Sleep apnea with an apnea-hypopnea index > 5/h
- •Restless legs syndrome with symptoms 3 days or more per week
- •Periodic limb movements during sleep with index > 15/h
- •REM-sleep behavior disorder
- •Narcolepsy and other central disorders of hypersomnolence
- •Sleepwalking more than once/month
- •Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months or expecting to do so during the study period
- •Severe mental disorders: bipolar disorder (Type I), schizophrenia, anxiety disorders, major depressive disorder, current substance use disorder, current post-traumatic stress disorder
- •Current suicidality
- •Frequent alcohol consumption (>10 glasses/week) or use of cannabis (more than once a week) or illicit drugs (more than once a month)
- •Smoking cigarettes more than 10 cigarettes/day
- •Pregnant or breastfeeding women
- •Current psychotherapy or past cognitive-behavioural therapy for insomnia
- •Current use of medication for depression or anxiety
- •Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment
- •For good sleepers: insomnia symptoms more than 3 times/ week.
研究组 & 干预措施
Immediate intervention
干预措施: Cognitive-Behavioural therapy for insomnia (CBT-I) (Behavioral)
Waitlist
结局指标
主要结局
Functional magnetic resonance imaging (fMRI) to examine brain responses to working memory with increasing task difficulty
时间窗: 3 months
Functional magnetic resonance imaging (fMRI) will be used to look at changes in brain activations to working memory in individuals with chronic insomnia compared to good sleepers, as well as the modifications in these brain activations after cognitive-behavioral therapy for insomnia.
Functional magnetic resonance imaging (fMRI) to examine brain responses to insomnia-related stimuli
时间窗: 3 months
Functional magnetic resonance imaging (fMRI) will be used to look at changes in brain activations to insomnia-related pictures in individuals with chronic insomnia compared to good sleepers, as well as the modifications in these brain activations after cognitive-behavioral therapy for insomnia.
Functional magnetic resonance imaging (fMRI) to examine brain responses to declarative memory encoding
时间窗: 3 months
Functional magnetic resonance imaging (fMRI) will be used to look at changes in brain activations to declarative memory encoding in individuals with chronic insomnia compared to good sleepers, as well as the modifications in these brain activations after cognitive-behavioral therapy for insomnia.
Functional magnetic resonance imaging (fMRI) to examine functional connectivity within the default-mode and limbic networks at rest
时间窗: 3 months
Functional magnetic resonance imaging (fMRI) will be used to look at changes in resting state functional connectivity in individuals with chronic insomnia compared to good sleepers, as well as the modifications in this functional connectivity after cognitive-behavioral therapy for insomnia, with a focus on the default-mode and limbic networks.
次要结局
- PSG wake-after-sleep-onset (WASO)(3 months)
- Insomnia Severity Index (ISI)(3 months and 1 year)
- Pittsburgh Sleep Quality Index (PSQI)(3 months and 1 year)
- Sleep latency(3 months)
- PSG total sleep time(3 months)
- Wake-after-sleep-onset (WASO)(3 months)
- PSG sleep efficiency(3 months)
- Spindle density(3 months)
- Dim light melatonin onset (DLMO)(3 months)
- Heart rate variability(3 months)
- Blood pressure(3 months)
- Circulating interleukin-6(3 months)
- Circulating tumor necrosis factor-alpha(3 months)
- Daytime Insomnia Symptom Response Scale (DISRS)(3 months and 1 year)
- Sleep efficiency(3 months)
- PSG sleep latency(3 months)
- Circulating C-reactive protein(3 months)
- Circulating neurotrophic factor BDNF(3 months)
- State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)(3 months and 1 year)
- Sahlgrenska Academy Self-reported Cognitive Impairment Questionnaire (SASCI-Q, adapted version)(3 months and 1 year)
- Work and Social Adjustment Scale (WSAS)(3 months and 1 year)
- Attention(3 months)
- GABA(3 months)
- Positive and Negative Affect Schedule(3 months and 1 year)
- Total sleep time(3 months)
- Diagnosis of insomnia disorder(3 months and 1 year)
- Sleep stage durations (N1, N2, N3, REM)(3 months)
- Arousal index(3 months)
- Beck Depression Inventory (BDI)(3 months and 1 year)
- Beliefs and Attitudes about Sleep (DBAS)(3 months and 1 year)
- Cortical thickness(3 months)
- Cortisol(3 months)
- Gray matter volume (GMV)(3 months)
- White matter integrity (fractional anisotropy, mean diffusivity)(3 months)
- Temporal experience of pleasure scale (adapted version)(3 months and 1 year)
- Munich Chronotype Questionnaire (MCTQ)(3 months and 1 year)
- The Implicit Positive and Negative Affect Test (IPANAT)(3 months and 1 year)
- Fatigue symptom inventory(3 months and 1 year)
- Subjective happiness scale(3 months and 1 year)
- Trier Inventory for Chronic Stress - short form(3 months and 1 year)
- Total sleep time(3 months and 1 year)
- Sleep latency(3 months and 1 year)
- Wake-after-sleep-onset (WASO)(3 months and 1 year)
- Sleep efficiency(3 months and 1 year)
研究者
Thanh Dang-Vu
Principal Investigator, Associate Professor
Concordia University, Montreal