Actively Recruiting
Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Led by Kaiser Permanente · Updated on 2025-12-15
300
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
K
Kaiser Permanente
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older and younger than 80 years
- Diagnosis of prediabetes
- Diagnosis of insomnia
- Regular access to a device with internet connection
- Adequate baseline data available
You will not qualify if you...
- Body mass index (BMI) over 40 kg/m2
- Sleep comorbidities noted in medical records or history
- Shift work or irregular sleep schedules imposed by external factors
- Moderate to severe obstructive sleep apnea detected during the study
- Completed a full course of cognitive behavioral therapy for insomnia within the last 12 months
- Current use of medications affecting blood sugar levels
- History of type 1 or type 2 diabetes or recent/planned use of diabetes medications such as metformin or insulin
- Recent or planned bariatric surgery within the next year
- Current or recent use of weight loss medications
- Unstable sleep medication regimen with recent changes in dose or schedule
- Significant health conditions that could interfere with therapy or increase risk
- Unwillingness or inability to limit heavy machinery use or long driving periods, or unstable illness worsened by sleep restriction
- High risk of falls
- Epilepsy
- Medical conditions interfering with digital CBT-I or contributing to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, chronic steroid use)
- Significant alcohol or substance use disorder
- Active or recent eating disorder or recent weight change greater than 10%
- Women who are pregnant, breastfeeding, or less than 1 year postpartum
- Use of hydroxyurea
- Extensive skin changes or adhesive allergy preventing use of continuous glucose monitoring sensor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Actively Recruiting
Research Team
S
Stefan Massimino, MS
CONTACT
C
Chris Catlin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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