Insomnia and Insulin Resistance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Missouri-Columbia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • sleep hygiene

    Behavioral

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: CBT-1Active comparator 1 intervention
Group B: sleep hygienePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

insulin resistance

HOMA-IR calculation

Time frame
baseline and through study completion, an average of 9 weeks

Secondary outcomes

1

sleep duration

measuring sleep duration with Actigraph

Time frame
baseline and through study completion, an average of 9 weeks

Other outcomes

Sponsors and contacts

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