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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713996
• Other study ID #: STUDY00142985
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive behavioral therapy for insomnia
CBT-I is designed to change sleep habits as well as direct misconceptions about sleep and insomnia. Participants will receive several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. The intervention will be provided in 6-session (one session/week).

Other:
• Health Education
Participants in this arm will receive education in sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity. The education will be provided in 6-session (1 session/week).

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index	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.	Insomnia severity will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph	Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep time (in minutes) divided by the mean of 7 nights of total sleep time (in minutes) multiply by 100). The range of Total Sleep Time variability is from 0% to 100%, with higher score indicating higher variability of Total Sleep Time.	The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph	Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total Wake after Sleep Onset (in minutes) divided by the mean of 7 nights of total Wake after Sleep Onset (in minutes) multiply by 100). The range of Wake after Sleep Onset variability is from 0% to 100%, with higher score indicating higher variability of Wake after Sleep Onset.	The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph	Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep latency (in minutes) divided by the mean of 7 nights of total sleep latency (in minutes) multiply by 100). The range of Sleep Latency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Latency.	The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph	Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of sleep efficiency (in percentage) divided by the mean of 7 nights of sleep efficiency (in percentage) multiply by 100). The range of Sleep Efficiency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Efficiency.	The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary	Sleep diary is a subjective gold stander sleep measures. Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep time (in minutes) divided by the mean of 7 nights of total sleep time (in minutes) multiply by 100). The range of Total Sleep Time variability is from 0% to 100%, with higher score indicating higher variability of Total Sleep Time.	The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Wake after Sleep Onset in Minutes using Subjective Measure, Sleep Diary	Sleep diary is a subjective gold stander sleep measures. Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total Wake after Sleep Onset (in minutes) divided by the mean of 7 nights of total Wake after Sleep Onset (in minutes) multiply by 100). The range of Wake after Sleep Onset variability is from 0% to 100%, with higher score indicating higher variability of Wake after Sleep Onset.	The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Sleep Latency in Minutes using Subjective Measure, Sleep Diary	Sleep diary is a subjective gold stander sleep measures. Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep latency (in minutes) divided by the mean of 7 nights of total sleep latency (in minutes) multiply by 100). The range of Sleep Latency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Latency.	The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in the Variability of Sleep Efficiency using Subjective Measure, Sleep Diary	Sleep diary is a subjective gold stander sleep measures. Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake. Sleep efficiency will be calculated based on the ratio of total sleep time and total time in bed multiply by 100. The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of sleep efficiency (in percentage) divided by the mean of 7 nights of sleep efficiency (in percentage) multiply by 100). The range of Sleep Efficiency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Efficiency.	The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
Secondary	Change in Fatigue Severity Scale Total Score	Fatigue Severity Scale is a validated 9-item questionnaire, to assess the fatigue in daily life and differentiate between fatigue and clinical depression. Total scores in which < 4 indicate no fatigue, scores between 4 and 4.9 indicate moderate fatigue, and score >5 indicate severe fatigue. The mean score of the nine items will be used, which ranges from 1 to 7.	Fatigue severity will be assessed at the baseline and 8 weeks.
Secondary	Change in Diabetes Self-Care Behavior using Diabetes Care Profile	Diabetes care profile is a validated instrument that measures self-reported diabetes control, psychological and social factors including Control Problems, Social and Personal Factors, Negative Attitude, Positive Attitude, Self-Care Adherence, and Diet Adherence. Each item on the Diabetes Care Profile is rated on 1 to 5 scales to evaluate the frequency of symptoms. Control Problems, Social and Personal Factors, and Negative Attitude are rated on a scale where 1 is good and 5 is poor; Positive Attitude, Self-Care Adherence, and Diet Adherence are rated on a scale where 5 is good and 1 is poor. Each sub-scale will represent an aspect in the diabetes self-care behavior.	Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks
Secondary	Change in Glycemic Control Level	Glycemic control will be tested using HbA1c testing Kit. HbA1c indicates the average blood glucose level of people with diabetes over the previous 2-3 months. Higher score on the A1C indicates poor glycemic control	A1C will be assessed at the baseline and 8 weeks.
Secondary	Change in Epworth Daytime Sleepiness Scale Total Score	The Epworth Sleepiness Scale will be utilized to evaluate the daytime sleepiness and subjectively investigate the likelihood of unintentionally falling asleep or increased difficulty in staying awake . It encompasses 8 items where the subjects rate how likely they would be to fall asleep in 8 different states of daily activities. A 4-point Likert scale ranging between 0 "never doze" and 3 "high chance of dozing". Total score will be used, which ranges from 0 to 24.	Daytime sleepiness will be assessed at the baseline and 8 weeks.
Secondary	Change in The Pittsburgh Sleep Quality Index Global Score	The Pittsburgh Sleep Quality Index is a validated 19-item questionnaire, and it differentiates between poor sleepers and good sleepers. it is derived from 7 items including perceived sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These items are separately scored from 0-3, with 3 representing the negative extreme, and summed to provide a global score. The total score of Pittsburgh Sleep Quality Index will be used, which ranges from 0 to 21. Higher scores indicate poor sleep quality.	Sleep quality will be assessed at the baseline and 8 weeks.
Secondary	Change in Random Glucose Level	Glucose meter will be utilized to assess the glucose level.	Random glucose level will be assessed at the baseline and 8 weeks.