Recruiting

CBT-I

Sponsor:

University of Missouri-Columbia

Code:

NCT07333586

Conditions

Insomnia

Insulin Resistance

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

CBT-I

sleep hygiene

Study Details

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

Study ID

NCT07333586

Start date

Sep 20, 2026

Status verified date

Sep, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CBT-1

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

placebo comparator: sleep hygiene

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

Interventions

CBT-I

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

sleep hygiene

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

Primary outcome measure

  • insulin resistance [ Time Frame: baseline and through study completion, an average of 9 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.