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临床试验/NCT07649408
NCT07649408招募中不适用

Impact of Advanced Crohn's Disease Therapies on Sleep Quality

Shmuel Kivity, MD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI)

研究概览

简要总结

The goal of this observational study is to measure changes in sleep quality before and after starting treatment with advance therapy in adult with Crohn disease. The main question it aims to answer is: what is the association between response to therapy and sleeping patterns? Participants who are about to begin advanced treatment will be asked to wear a Fitbit device before end after treatment initiation to monitor sleep patterns and sleep quality, complete a sleep diary and a sleep quality questionnaire. The follow-up period will last 26 weeks, during which disease severity and response to treatment will be assessed.

详细描述

Inflammatory bowel diseases (IBD) are chronic inflammatory diseases with a relapsing remitting course. The pathogenesis of the disease is hypothesized to be abnormal host immune response to the gut microbiota, triggered by dietary, environmental or stress factors in genetically predisposed individuals. Despite the significant medical progress with the advent of therapy (e.g., TNF, integrin and cytokine inhibitors, jak inhibitors and S1P receptor modulators) there are still many caveats in the treatment of patients with IBD, including loss of response, immunogenicity, immunosuppression and side effects. Furthermore, although current therapies improve health associated quality of life, there is still unmet gap in this area with high rates of disability, sleep disturbances, fatigue, pain and other quality of life domains.

Sleep and circadian rhythm disorders effect the immune system function and are a potential cause of disease flare-ups, which in turn effect sleep pattern and quality, creating a vicious cycle. The interactions between sleep and inflammation are complex. An effective immune system affects sleep, and sleep disorders affect the functioning of the immune system. Patients with sleep disorders showed increase in inflammatory activity. However, it is difficult to dissect the cause and effect for these associations, given their complex interactions.

Studies identified several risk factors associated with sleep disorders in patients with IBD. These include depression, anxiety, active disease, older age (>52 years), CD duration (>12 years), low hemoglobin levels (<12 g/dL), elevated C-reactive protein (CRP), current corticosteroid use, ongoing anti-TNF therapy, opioid use, and smoking.

Previous studies on the association of sleep abnormalities and IBD relied on self-assessment questionnaires, such as the Pittsburgh Sleep Quality Index (PSQI), which are inherently subjective measures of sleep quality. In this study, the investigators will use the Fitbit Inspire 3 to objectively assess sleep quality, leveraging its ability to track sleep duration and stages.

Sleep is a vital physiological process encompassing two primary modes: Non-Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) sleep. NREM sleep, divided into stages N1, N2, and N3. In N1, the body starts to relax; N2 brings deeper relaxation with a slower heart rate; and in N3, the deepest stage. REM sleep, characterized by vivid dreaming and heightened brain activity similar to wakefulness, is essential for cognitive functions like memory consolidation, emotional processing, and learning. Throughout the night, individuals cycle through NREM and REM phases, each contributing uniquely to physical and mental well-being, underscoring the importance of quality sleep for overall health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with established diagnosis of Crohn's Disease
  • Patients with active inflammation, defined as HBI score ≥ 5 and either CRP>5 or stool calprotectin>250 mcg/gr.
  • Patients starting advanced treatment as part of routine medical care (Anti TNFs, vedolizumab, Ustekinumab, IL-23 inhibitors, Jak inhibitors or S1P inhibitors).

排除标准

  • Inability to give informed consent and complete the study protocol.
  • Pregnant or lactating women
  • Inability or reluctance to follow through with the study protocol, including (but not exclusive) to: questionnaires, wearing the watch while sleeping.
  • Patients diagnosed with UC or indeterminate IBD.
  • Other sleep disorders Obstructive sleep apnea overactive bladder insomnia shift work disorder restless leg syndrome Periodic limb movement of sleep Narcolepsy
  • Use of sleep medication - such as benzodiazepines or cannabis.
  • Recent abdominal surgery - previous 4 weeks.
  • Severe systemic disease - CVD, Kidney, liver - as jugged by physician's discretion.
  • Patients with ileostomy or short bowl syndrome.

研究组 & 干预措施

Crohn disease patients

Patients starting advanced treatment as part of routine medical care

干预措施: Wearable activity and sleep tracker (Other)

结局指标

主要结局

Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI)

时间窗: Week 8

Proportion of patients achieving improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI). Improvement is defined as a decrease of ≥3 points from baseline PSQI global score. Scores range from 0 to 21, with higher scores indicating worse sleep quality and greater sleep disturbance.

次要结局

  • Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI)(Week 4)
  • Change in sleep onset latency(Week 4)
  • Change in sleep onset latency(Week 8)
  • Time in Rapid Eye Movement (REM) sleep(Week 8)
  • Change in wake after sleep onset (WASO)(Week 4)
  • Change in wake after sleep onset (WASO)(Week 8)
  • Change in total sleep time(Week 4)
  • Change in total sleep time(Week 8)
  • Time in Rapid Eye Movement (REM) sleep(Week 4)
  • Time in light sleep(Week 4)
  • Time in light sleep(Week 8)
  • Time in deep sleep(Week 4)
  • Time in deep sleep(Week 8)
  • Fecal calprotectin(Week 4)
  • Fecal calprotectin(Week 8)
  • C-reactive protein (CRP)(Week 4)
  • C-reactive protein (CRP)(Week 8)
  • Harvey bradshaw index (HBI)(Week 4)
  • Harvey bradshaw index (HBI)(Week 8)
  • Clinical remission according to HBI(Week 4)
  • Clinical remission according to HBI(Week 8)

研究者

发起方
Shmuel Kivity, MD
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Shmuel Kivity, MD

Professor

Tel-Aviv Sourasky Medical Center

研究点 (1)

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