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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT06067139

Run by

Kaiser Permanente

People needed

300

Starts

2023-08-01

Expected to finish

2027-12-01

Last updated by the study team

2025-12-15

Who can join

Age: 22 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente Center for Health Research — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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