The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes

Insomnia Clinical Trial

Official title: Insomnia and Type 2 Diabetes: Measurement, Impact and Intervention

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Type2 Diabetes

• NCT number: NCT03713996
• Study type: Interventional
• Source: University of Kansas Medical Center
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Completion date: June 1, 2019