Last updated: October 5, 2021
Sponsor: Montana State University
Overall Status: Active - Recruiting
Phase
4
Condition
Insomnia
Restless Leg Syndrome
Treatment
N/AClinical Study ID
NCT03768713
JC101320-FC
Ages 18-65 All Genders
Study Summary
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
Connect with a study center
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Michigan Technological University
Houghton, Michigan 49931
United StatesSite Not Available
Montana State University
Bozeman, Montana 59717
United StatesActive - Recruiting
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