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New treatment option for Diabetes Mellitus, Type 2
Official title Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
ClinicalTrials.gov ID: NCT06067139
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 79
You may be able to join if
- Age ≥ 22 years and \< 80 years of age
- Prediabetes
- Insomnia
- Regular access to device with internet access
- Adequate data at baseline
You likely can't join 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:
See the full eligibility criteria
- Age ≥ 22 years and \< 80 years of age
- Prediabetes
- Insomnia
- Regular access to device with internet access
- Adequate data at baseline
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.