Insomnia and Insulin Resistance

NCT07333586 | Not Yet Recruiting

• 1 other identifier: insomnia
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. Chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States. The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. This study will explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.) and provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population. 20 subjects with insomnia will be recruited. They will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigator will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.

Conditions

Insomnia; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• insulin resistance

  HOMA-IR calculation

  baseline and through study completion, an average of 9 weeks

Secondary Outcomes (1)

• sleep duration

  baseline and through study completion, an average of 9 weeks

Study Arms (2)

CBT-1

ACTIVE COMPARATOR

treatment with cognitive behavior therapy for insomnia this is behaviorial therapy that meets with a "coach" once a week for 5 wk

Behavioral: CBT-I

sleep hygiene

PLACEBO COMPARATOR

treatment with sleep hygiene group meets with a coach once at the beginning of the intervention period

Behavioral: sleep hygiene

Interventions

CBT-I BEHAVIORAL

meets with "coach" who is teaching the participant how to deal with insomnia meets 5 times/once a week with the coach

CBT-1

sleep hygiene BEHAVIORAL

meets with coach 1 time and is teaching the participant how to improve their sleep

sleep hygiene

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-50 y BMI 28-45 kg/m2 Score on the Insomnia Severity Index ≥15.

You may not qualify if:

• contraindications for CBT-I (mania or seizure disorder) symptoms requiring immediate attention (e.g., psychosis, suicide intent) report illicit substance use on a monthly basis (e.g., cocaine, opioids) receiving behavioral treatment for insomnia overt cardiovascular disease overt renal disease thyroid disease cancer pregnant dieting using GLP-1 agonists taking exogenous insulin

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Matt McDonald, MS

CONTACT

5737722519; mjmdr4@missouri.edu

Jill Kanaley, PhD

CONTACT

5737722519; kanaleyj@missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share