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

NCT ID: NCT03768713

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2023-04-30

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 will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.

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 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.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Drug (Suvorexant)

20 mg of Suvorexant daily (taken orally \~1 hour before bedtime)

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.

Placebo

20 mg of Placebo daily (taken orally \~1 hour before bedtime)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.

Interventions

Suvorexant

Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.

Intervention Type: DRUG

Placebo

Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.

Intervention Type: DRUG

Eligibility Criteria

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 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

Montana State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Carter, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

Montana State University

Bozeman, Montana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne Tikkanen

Role: CONTACT

anne.tikkanen@montana.edu

406-994-2292

Jeremy Bigalke

Role: CONTACT

jeremy.bigalke@student.montana.edu

406-994-2292

Facility Contacts

Anne Tikkanen

Role: primary

anne.tikkanen@montana.edu

406-994-2292

Other Identifiers

JC101320-FC

Identifier Type: -

Identifier Source: org_study_id