Insomnia and Type 2 Diabetes: Measurement, Impact and Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index
研究概览
简要总结
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue and inconstant sleep schedule, which negatively influence quality of life. However, the additive effect of behavioral sleep intervention on diabetes outcomes and health status in people with T2D is unknown. Therefore, The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.
详细描述
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue, which negatively influences quality of life. However, the additive effect of insomnia symptoms on diabetes outcomes and health status in people with T2D is unknown. Therefore, it is imperative to investigate the contributing factor that affects DSCB and health outcomes to help individuals with diabetes reach their goals.
Assessing sleep variability is very important clinically and practically for people with insomnia. People with insomnia have higher night to night sleep variability compared to healthy individuals. Compared to other populations, people with T2D might suffer from sleep disturbances due to diabetes symptoms such as frequency nocturnal urination, hyperglycemia, insulin resistance, obesity, pain and fatigue, which might influence the sleep variability. The nature of insomnia is not representable by using mean values, as the reduction in the sleep variability values is a predictor for insomnia and depression recovery. Therefore, understanding the sleep variability in people with T2D with or without insomnia symptoms may add complementary evidence for future studies.
An effective treatment for people with insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is superior to sleep medications in terms of cost and long term benefits. Although there is currently limited evidence about the effect of CBT-I on people with T2D, CBT-I is a potentially effective intervention given insomnia's relationship with glucose metabolism. The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 to 75 years
- •Self-reported diagnosis of type 2 diabetes
- •Insomnia Severity Index >10 and self-reported symptoms of insomnia at least 3 nights/week for the past 3 months for insomnia and type 2 diabetes group
- •Insomnia Severity Index ≤10 for type 2 diabetes only group
- •Able to attend 6 sessions
- •Able to understand and follow verbal commands in English
- •Able to travel to our lab
排除标准
- •Self-reported neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, Traumatic Brain Injury, Stroke, Multiple Sclerosis)
- •Stop-Bang > 4 indicating severe risk of sleep apnea
- •Failure to pass Restless Leg Syndrome Diagnostic Index
- •Severe pain ≥ 7 out of 10 on Brief Pain Inventory
- •Severe symptom level of depression scores ≥ 21 on Beck Depression Inventory
- •Severe symptom level of anxiety scores ≥ 15 on Generalized Anxiety Scale-7
- •Pregnant women
- •Self-reported following medical issues: Chronic Fatigue Syndrome, Fibromyalgia, and Rheumatic Diseases
- •Speech deficits or significant auditory impairment
- •Night-shift work
- •Self-reported Bipolar and Seizure Disorders
- •Heavy alcohol drinker (≥15 drinks per week for men and ≥ 8 drinks per week for women)
- •Dialysis/blindness/trans-femoral amputation
研究组 & 干预措施
CBT-I intervention
The intervention includes several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
Diabetes Education
Sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity will be delivered for the Health Education group. During all sessions, subjects will be encouraged to engage in the discussion through open questions about their experience in diabetes, lifestyle, and understanding about provided materials.
干预措施: Health Education (Other)
结局指标
主要结局
Change in Insomnia Severity Index
时间窗: Insomnia severity will be assessed at the baseline and 8 weeks.
The Insomnia Severity Index is a self-report measure designed to evaluate the nature, severity, and impact of insomnia.Seven-items assess severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress due to the sleep difficulties.This is self-reported seven items on a five-point Likert scale from zero (not at all satisfied) to four (very much satisfied). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
次要结局
- Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph(The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph(The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph(The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary(The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph(The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in the Variability of Sleep Efficiency using Subjective Measure, Sleep Diary(The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in Glycemic Control Level(A1C will be assessed at the baseline and 8 weeks.)
- Change in Diabetes Self-Care Behavior using Diabetes Care Profile(Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks)
- Change in the Variability of Wake after Sleep Onset in Minutes using Subjective Measure, Sleep Diary(The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in Fatigue Severity Scale Total Score(Fatigue severity will be assessed at the baseline and 8 weeks.)
- Change in the Variability of Sleep Latency in Minutes using Subjective Measure, Sleep Diary(The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.)
- Change in Epworth Daytime Sleepiness Scale Total Score(Daytime sleepiness will be assessed at the baseline and 8 weeks.)
- Change in The Pittsburgh Sleep Quality Index Global Score(Sleep quality will be assessed at the baseline and 8 weeks.)
- Change in Random Glucose Level(Random glucose level will be assessed at the baseline and 8 weeks.)
研究者
Patricia Kluding, PhD
Professor and Chair, Department of Physical Therapy and Rehabilitation Science
University of Kansas Medical Center