RecruitingNot ApplicableNCT06067139

Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Sponsor

Kaiser Permanente

Enrollment

300 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Prediabetic State Sleep Initiation and Maintenance Disorders

Summary

This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.

Eligibility

Min Age: 22 YearsMax Age: 79 Years

Inclusion Criteria5

Age ≥ 22 years and \< 80 years of age
Prediabetes
Insomnia
Regular access to device with internet access
Adequate data at baseline

Exclusion Criteria20

BMI \> 40 kg/m2
Sleep comorbidities detected in medical record or via medical history
Shift work or significant, externally imposed irregular sleep schedule
moderate to severe OSA by home sleep apnea test as part of trial protocol
Received a full course of CBT-I in the last 12 months
Current use of medication with glycemic effects:
History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin)
Recent history of bariatric surgery or planning bariatric surgery in the next year
Current or recent use of weight loss meds
Unstable sleep medication regimen (recent change to schedule or dosage)
Significant comorbidity that may interfere with CBT-I uptake or increase risks
Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction
High risk of falls
Epilepsy
Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)
Significant alcohol or substance use disorder
Active or recent history of eating disorder, recent weight change of \>10%
Women: pregnancy (current or planned), breastfeeding, \< 1 year postpartum
Use of hydroxyurea
Extensive skin changes or adhesive allergy making CGM sensor use problematic

Interventions

OTHERSHUTi

Each core includes a variety of interactive features, such as animations, vignettes, "myth" and "reality" buttons that reveal common misperceptions and facts about sleep, "learn more" buttons that provide in-depth information about a topic, and quizzes. All cores follow a similar structure with objectives, main content, homework, and review. Participants are free to revisit cores as many times as they like.

OTHERPatient Education

The PE website will present content in a simple, static form, without interactive components; and all content on the website will be provided at once, rather than in modules that unlock over time. The PE website will also not provide personalized or individually tailored treatment recommendations.