Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-79
SponsorKaiser Permanente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 22 years and < 80 years of age
Prediabetes
Insomnia
Regular access to device with internet access
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SHUTi
Other interventionEach core includes a variety of interactive features, such as animations, vignettes, "myth" and "reality" buttons that reveal common misperceptions and facts about sleep, "learn more" buttons that provide in-depth information about a topic, and quizzes. All cores follow a similar structure with objectives, main content, homework, and review. Participants are free to revisit cores as many times as they like.
Patient Education
Other interventionThe PE website will present content in a simple, static form, without interactive components; and all content on the website will be provided at once, rather than in modules that unlock over time. The PE website will also not provide personalized or individually tailored treatment recommendations.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Digital cognitive behavioral therapy (dCBT-I)Experimental treatment 1 intervention
Group B: Patient Education (PE)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
2-hour post-load glucose (2hPG) (mg/dL)
2-hour post-load glucose (mg/dL)
Time frame
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)Secondary outcomes
1
Hemoglobin A1c (A1C) (percentage)
Plasma HgB A1C (percentage)
Time frame
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)2
Fasting plasma glucose (FPG) (mg/dL)
Fasting plasma glucose levels (mg/dL)
Time frame
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)3
Mean glucose on CGM (mg/dL)
Average blood glucose levels throughout CGM wear duration (mg/dL)
Time frame
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)4
Insulin resistance score (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L)
Insulin resistance score - (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L)
Time frame
V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaiser Permanente
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov