Abstract
BACKGROUND: Insomnia is a modifiable risk factor for type 2 diabetes. OBJECTIVE: Describe the methodology for the Sleep for Health study, a randomized clinical trial examining the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) in reducing hyperglycemia in 300 people with both insomnia and prediabetes. OUTCOMES: Primary outcome is glucose level 2 h after a 75-g glucose load. Secondary outcomes include fasting glucose, hemoglobin A1c, insulin resistance score, mean glucose from continuous glucose monitoring (CGM), standard deviation of CGM values, and number of CGM values >140 mg/d. METHODS: Participants with a hemoglobin A1c in the prediabetes range (5.7 % to 6.4 %) and clinically significant insomnia are randomized to a dCBT-I program or patient education control program. dCBT-I includes six sessions that focus on changing sleep habits and scheduling factors that affect sleep and addresses misconceptions about sleep and insomnia, utilizing interactive components and goal-setting. Those in the control arm receive access to a sleep-education website, which presents informational content in a simple, static form, without interactive components or active skills training, and all content is provided at once, rather than in modules that unlock over time. At baseline, 11 weeks and 33 weeks after randomization, participants undergo laboratory testing with a 2-h oral glucose tolerance test, hemoglobin A1c, and insulin resistance score. They also undertake 10 days of CGM and actigraphy wear and complete two dietary recalls. SUMMARY: This trial is testing whether a program to improve sleep will positively impact glycemia among those with prediabetes. Registration with clinicaltrials.gov on October 3, 2023: NCT06067139.