Status:
UNKNOWN
Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
Lead Sponsor:
Montana State University
Collaborating Sponsors:
University of Chicago
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 wi...
Detailed 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 ba...
Eligibility Criteria
Inclusion
- 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 will be scheduled for microneurography 2-7 days after menstruation to consistently test during the early follicular phase (or low-hormone phase in women on contraceptives)
Exclusion
- Current or prior treatment of Suvorexant.
- Obstructive sleep apnea defined as an apnea-hypopnea index \> 30 using an FDA approved home sleep apnea screening devices as used in routine clinical practice.
- Participants without evidence of clinically significant obstructive sleep apnea on the screening test will undergo an overnight in-laboratory polysomnography to confirm absence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to exclude other sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes per hour)
- Circadian rhythm sleep disorders
- History of meeting DSM-V criteria of major psychiatric disorder
- Have been clinically-diagnosed with diabetes, cardiovascular disease, or any other unstable or serious medical condition.
- Current, or use within past month, of psychoactive (other than stable treatment with antidepressant or antianxiety), hypnotic, stimulant or analgesic medication (except occasional 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
Key Trial Info
Start Date :
April 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03768713
Start Date
April 18 2019
End Date
April 1 2023
Last Update
October 7 2021
Active Locations (1)
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1
Montana State University
Bozeman, Montana, United States, 59717