Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia

Last updated: October 5, 2021
Sponsor: Montana State University
Overall Status: Active - Recruiting

Phase

4

Condition

Insomnia

Restless Leg Syndrome

Treatment

N/A

Clinical Study ID

NCT03768713
JC101320-FC
  • Ages 18-65
  • All Genders

Study Summary

This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Minimum 3 months of clinically diagnosed insomnia
  • Body mass index ≤35 kg/m2
  • Insomnia Severity Index (ISI) > 7 arbitrary units (i.e., mild-to-severe insomnia)
  • Pre-menopausal women must have regular menstrual cycles (~26-30 day cycles) and willbe scheduled for microneurography 2-7 days after menstruation to consistently testduring the early follicular phase (or low-hormone phase in women on contraceptives)

Exclusion

Exclusion Criteria:

  • Current or prior treatment of Suvorexant.
  • Obstructive sleep apnea defined as an apnea-hypopnea index > 30 using an FDA approvedhome sleep apnea screening devices as used in routine clinical practice.
  • Participants without evidence of clinically significant obstructive sleep apnea on thescreening test will undergo an overnight in-laboratory polysomnography to confirmabsence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to excludeother sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes perhour)
  • Circadian rhythm sleep disorders
  • History of meeting DSM-V criteria of major psychiatric disorder
  • Have been clinically-diagnosed with diabetes, cardiovascular disease, or any otherunstable or serious medical condition.
  • Current, or use within past month, of psychoactive (other than stable treatment withantidepressant or antianxiety), hypnotic, stimulant or analgesic medication (exceptoccasional non-narcotic analgesics)
  • Shift work or other types of self-imposed irregular sleep schedules
  • Habitual smoking (6 or more cigarettes per week)
  • Habitual alcohol consumption (more than 2 alcoholic drinks per day)
  • Breastfeeding or pregnancy

Study Design

Total Participants: 34
Study Start date:
April 18, 2019
Estimated Completion Date:
April 30, 2023

Study Description

This study will utilize a randomized, double-blind, placebo-controlled experimental approach to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve activity and baroreflex function in male and female subjects with chronic insomnia. The study will utilize established techniques for assessing sleep (polysomnography), blood pressure (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve activity (microneurography). The study will stratify enrollment based upon both age and sex (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve activity and baroreflex function.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Michigan Technological University

    Houghton, Michigan 49931
    United States

    Site Not Available

  • Montana State University

    Bozeman, Montana 59717
    United States

    Active - Recruiting

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