RECRUITING

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

Conditions

Diabetes Mellitus, Type 2 Prediabetic State Sleep Initiation and Maintenance Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-01

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06067139

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.

Ages Eligible for Study:22 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Stefan Massimino, MS

CONTACT

971-232-9343

stefan.massimino@kpchr.org

Chris Catlin

CONTACT

971-369-0655

chris.l.catlin@kpchr.org

Principal Investigator

Erin LeBlanc, MD

PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Study Locations (Sites)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227

United States

Collaborators and Investigators

Sponsor: Kaiser Permanente

Erin LeBlanc, MD, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2027-03

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Prediabetic State
Sleep Initiation and Maintenance Disorders