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

Description

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.

Study Overview

Study Details

Study overview

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.

Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

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

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Portland

Kaiser Permanente Center for Health Research, Portland, Oregon, United States, 97227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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
  • * 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

Ages Eligible for Study

22 Years to 79 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kaiser Permanente,

Erin LeBlanc, MD, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Study Record Dates

2027-03