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临床试验/NCT06550388
NCT06550388已完成不适用

Effect of Brief Lifestyle Interventions on the Subjective Sleep Quality of Patients With Chronic Insomnia

Mayo Clinic4 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年9月10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
发起方
Mayo Clinic
入组人数
5
试验地点
4
主要终点
Change in sleep quality measured by the Pittsburgh Sleep Quality Index

研究概览

简要总结

The purpose of this study is to assess subjective sleep quality, diet quality, physical activity in patients with chronic insomnia before and after a brief lifestyle intervention during a traditional course of Cognitive Behavioral Therapy for Insomnia (CBT-I)

详细描述

Chronic insomnia disorder is highly prevalent, occurring in 4% to 22% of the population in the U.S. The consequences of chronic insomnia are significant including mood disorders, work-related and motor vehicle accidents, and overall poor quality of life. Lack of sleep satisfaction, a hallmark of chronic insomnia, is associated with metabolic syndrome, diabetes, hypertension, coronary heart disease and depression1.

Chronic insomnia is predominantly managed with hypnotics and other medications despite the effectiveness of and patient preference for CBT-I. The American College of Physicians (ACP) and the American Academy of Sleep Medicine (AASM) guidelines for management of chronic insomnia recommend all patients receive Cognitive Behavioral Therapy for Insomnia (CBT-I) as first line treatment for chronic insomnia2,3. CBT-I is a structured, nonpharmacological treatment that uses educational, cognitive, and behavioral strategies. Meta-analyses have shown CBT-I is consistently associated with improved sleep quality in chronic insomnia with or without comorbidities4,5. While the strategies associated with CBT-I have been found to be effective for the management of chronic insomnia, lifestyle intervention to improve patients' diet and physical activity is not part of traditional CBT-I. The field of behavioral sleep medicine can expand interventional strategies to promote health and well-being while also optimizing sleep health.

A pathway to improve sleep health is a shift from a typical medicine perspective which emphasizes identification and treatment of symptoms, to a health promotion perspective, which emphasizes the promotion of overall well-being. Incorporating principles from lifestyle medicine and behavioral sleep medicine can both identify and treat sleep disorders plus promote overall health including education regarding diet quality and exercise. Targeting diet quality and physical activity education within the context of CBT-I will underscore the importance of nonpharmacological treatment and the promotion of health and well-being which is central to behavioral sleep and lifestyle medicine.

The etiology of chronic insomnia disorder is multifactorial with research supporting poor diet and lack of physical activity as contributing factors to poor sleep. Previous studies have reported higher diet quality promotes better sleep quality and mental health. Sleep deprivation and sleep disturbances have been linked to poor diet quality. Eating too quickly or skipping meals, overabundant meals, irregular mealtimes, and poor food quality, all are dietary causes of sleep disorders. Additionally, the timing of meals, including frequency and regularity of snacks, may desynchronize circadian rhythm, affect metabolism, and favor obesity6. There is mounting evidence suggesting sleep influences dietary choices as well. Individuals who sleep less are more likely to prefer energy-rich foods (e.g., fats and refined carbohydrates), eat fewer vegetables, and choose irregular eating patterns7.

Additionally, several pathways have been proposed regarding benefits of the Mediterranean diet and healthy dietary patterns on sleep, including the role of the gut microbiome8, inflammation and the consumption of dietary tryptophan and melatonin9. Some observational studies have shown a high intake of fruit and vegetables is associated with better sleep quality and lower risk of insomnia while a cohort study of older adults in Spain showed that higher consumption of red meat was associated with poor sleep quality and snoring10,11.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Chronic Insomnia
  • 18-70 years of age

排除标准

  • Known untreated sleep disorder
  • Cardiovascular diagnosis that would not allow safe increase of physical activity
  • Pregnancy or lactation
  • Current use of a vegan diet or Mediterranean diet
  • Score higher than 15 on PHQ-8
  • Diagnosed with a severe neurological or sensory impairment that would significant impact participation
  • Currently performing shift work/diagnosis of a circadian rhythm disorder

研究组 & 干预措施

Physical Activity Education

Other

In addition to the traditional course of CBT-I, the PI will recommend patient to increase physical activity minutes per week. The increase in physical activity will be based on patient's current level of physical activity.

干预措施: Physical Activity (Behavioral)

Nutritional Education

Other

In addition to the traditional course of CBT-I, the PI will provide education and materials regarding the Mediterranean Diet. Patient will be provided with the Mayo Clinic booklet on Mediterranean Diet and asked to increase their daily intake in two categories assessed by the Mini-EAT.

干预措施: Nutritional Education (Behavioral)

结局指标

主要结局

Change in sleep quality measured by the Pittsburgh Sleep Quality Index

时间窗: Baseline, 84 days

Measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.

次要结局

  • Change in insomnia measured by the Insomnia Severity Index(Baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexa Kane

Principal Investigator

Mayo Clinic

研究点 (4)

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