Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Recruiting · NCT06067139 · Interventional (participants receive a specific treatment) · Lead sponsor: Kaiser Permanente
View the official record on ClinicalTrials.gov →Interventions studied
Patient EducationSHUTi
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.
Who can take part
Age range
22 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Kaiser Permanente Center for Health Research - Portland, Oregon, United States