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

Launched by KAISER PERMANENTE · Sep 27, 2023

Keywords

ClinConnect Summary

The Sleep for Health Study is looking at how a type of therapy called cognitive behavioral therapy for insomnia (CBT-I) can help people with prediabetes. The main goal of the study is to see if this therapy can lower blood sugar levels, which is important for preventing diabetes. Participants will be compared to a group that receives general education about health, to see which approach works better for managing blood sugar and sleep issues.

To be eligible for this study, you should be between 22 and 79 years old, have prediabetes, and experience insomnia or trouble sleeping. You’ll need access to the internet for the study activities. If you have certain health conditions, such as a very high body mass index (BMI), recent weight changes, or are currently taking medications that affect blood sugar, you may not qualify. Participants can expect to learn about improving their sleep through therapy sessions and track their progress over time. This study is currently looking for volunteers, and your involvement could help improve understanding of how better sleep can impact diabetes risk.

Gender

ALL

Eligibility criteria

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