NCT06067139Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 31 Jul 2023
- Start date
- 1 Aug 2023
- Primary completion date
- Mar 2027
- Lead sponsor
- Kaiser Permanente
- Diseases
- Type 2 diabetes
- NCT number
- NCT06067139
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Aug 2023 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received a full course of CBT-I in the last 12 months
- Current use of medication with glycemic effects:
- Unstable sleep medication regimen (recent change to schedule or dosage)
Other illness
- 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
- Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction
- 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%
- Extensive skin changes or adhesive allergy making CGM sensor use problematic
Other
- 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
- Current or recent use of weight loss meds
- Significant comorbidity that may interfere with CBT-I uptake or increase risks
- High risk of falls
- Women: pregnancy (current or planned), breastfeeding, \< 1 year postpartum
- Use of hydroxyurea
Who the study is looking for
- Age ≥ 22 years and \< 80 years of age
- Prediabetes
- Insomnia
- Regular access to device with internet access
- Adequate data at baseline
Age in the registry: 22 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiser Permanente Center for Health Research Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.