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Insomnia and Insulin Resistance

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Jun 1, 2026 to Sep 20, 2026
    • Study sites: 0 to 1
    • Study description expanded, about 4 words
  2. Start date: Feb 1, 2026 to Jun 1, 2026
    • Primary and study completion pushed from Feb 1, 2027 to Jun 1, 2027
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07333586
Lead Sponsor University of Missouri-Columbia
Conditions
(from sponsor)		 Insomnia, Insulin Resistance
Related terms Insulin Resistance, Sleep Initiation and Maintenance Disorders
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov