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Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Sponsor
Kaiser Permanente (Other)
Overall Status
Recruiting
CT.gov ID
NCT06067139
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
300
Enrollment
1
Location
2
Arms
43
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SHUTi
  • Other: Patient Education
 N/A

Detailed Description

Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected that one in three Americans will have T2D by 2050. To stem the tide of this health crisis, new strategies are needed to prevent the progression to T2D from prediabetes-elevated glucose levels that are not yet in the diabetes range. A growing body of research suggests that insomnia is a major modifiable risk factor for progression to diabetes. The proposed study would build off a promising feasibility study to test whether providing cognitive behavioral therapy for insomnia (CBT-I) to patients with prediabetes results in a reduction in glucose levels compared to a patient education control program. If so, this insomnia treatment could be an effective tool to prevent diabetes.

Individuals with prediabetes and insomnia will be randomized to receive six sessions of a deployment-ready digital CBT-I program, providing standard-of-care treatment for insomnia (intervention arm, n = 150), or a patient education website providing nontailored material about insomnia (control arm, n = 150). The investigators will complete assessments at baseline, at 11 weeks (after the conclusion of the intervention and control programs), and at 33 weeks post-baseline, measuring hyperglycemia, objective and subjective measures of sleep, and potential mediating variables including diet, exercise, and mood.

The investigators will assess (1) whether individuals randomized to the intervention arm have lower rates of hyperglycemia, as measured by oral glucose tolerance testing and various secondary measures, than individuals randomized to the control arm at 11 weeks and 33 weeks after baseline; (2) whether improvements in sleep after baseline are associated with decreases in hyperglycemia, regardless of study arm; and (3) whether any effects of the intervention on hyperglycemia are mediated by improvements in sleep, diet, exercise, and/or mood.

This research will serve as a critical step in identifying a potentially dramatic tool for improving health outcomes for Americans at risk of T2DM. Sleep interventions can lead to sustained improvements that are intrinsically rewarding to patients. If effective, digital CBT-I could provide a powerful pathway to preventing diabetes for millions of patients with prediabetes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital cognitive behavioral therapy (dCBT-I)

CBT-I is designed to change sleep habits and scheduling factors that affect sleep, and to address misconceptions about sleep and insomnia that perpetuate sleep difficulties. The investigators will employ SHUTi, which is an extensively studied dCBT-I program. SHUTi is intended to improve insomnia symptoms by providing neurobehavioral intervention (cognitive behavioral therapy for insomnia - CBT-I) in adults with chronic insomnia. It is a six-core internet-delivered CBT-I web-based app that is run through a browser. It is accessible via iPhone/iPad, Android phone/tablet, computer or laptop (any device with a browser). SHUTi follows evidence-based CBT-I principles.

Other: SHUTi
Each 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.
Active Comparator: Patient Education (PE)

Participants will be given access to a patient education website. It will provide nontailored material about insomnia symptoms; the impact, prevalence, and causes of insomnia; and basic lifestyle, environmental, and behavioral strategies to improve sleep.

Other: Patient Education
The 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.

Outcome Measures

Primary Outcome Measures

  1. 2-hour post-load glucose (2hPG) (mg/dL) [V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

    2-hour post-load glucose (mg/dL)

Secondary Outcome Measures

  1. Hemoglobin A1c (A1C) (percentage) [V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

    Plasma HgB A1C (percentage)

  2. Fasting plasma glucose (FPG) (mg/dL) [V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

    Fasting plasma glucose levels (mg/dL)

  3. Mean glucose on CGM (mg/dL) [V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

    Average blood glucose levels throughout CGM wear duration (mg/dL)

  4. Insulin resistance score (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L) [V1 (baseline), V2 (11 weeks after randomization), V3 (33 weeks from randomization)]

    Insulin resistance score - (probability ranking, Calculated using the insulin and C-peptide concentrations converted to pmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Center for Health Research Portland Oregon United States 97227

Sponsors and Collaborators

  • Kaiser Permanente
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Erin LeBlanc, MD, Kaiser Permanente

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT06067139
Other Study ID Numbers:
  • R01DK132229
  • 1R01DK132229-01A1
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State

Study Results

No Results Posted as of Oct 4, 2023