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

NCT03768713 | Unknown Phase 4 FDA Drug

• 1 other identifier: JC101320-FC
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (2)

• Sympathetic nerve activity

  Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.

  8 weeks

• Baroreflex sensitivity

  The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.

  8 weeks

Secondary Outcomes (3)

• Sympathetic reactivity

  8 weeks

• Home sleep quality: Wrist actigraphy

  8 weeks

• Laboratory sleep quality: Polysomnography

  8 week

Study Arms (2)

Drug (Suvorexant)

EXPERIMENTAL

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

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Suvorexant DRUG

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

Drug (Suvorexant)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead
• University of Chicago: collaborator

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jason Carter, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Tikkanen

CONTACT

406-994-2292; anne.tikkanen@montana.edu

Jeremy Bigalke

CONTACT

406-994-2292; jeremy.bigalke@student.montana.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: April 18, 2019
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)