| NCT ID | NCT07333586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-09-20 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-09-20 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07333586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07333586 currently recruiting?
Yes, NCT07333586 is actively recruiting participants. Contact the research team at kanaleyj@missouri.edu for enrollment information.
Where is the NCT07333586 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT07333586 clinical trial?
NCT07333586 is sponsored by University of Missouri-Columbia. The trial plans to enroll 20 participants.
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