Recruiting

Suvorexant

Sponsor:

Montana State University

Code:

NCT03768713

Conditions

Chronic Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Suvorexant

Placebo

Study Details

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

Study ID

NCT03768713

Start date

Apr 18, 2019

Status verified date

Oct, 2021

Completion date

Apr, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Drug (Suvorexant)

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

placebo comparator: Placebo

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

Interventions

Suvorexant

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

Placebo

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

Primary outcome measure

  • Sympathetic nerve activity [ Time Frame: 8 weeks ]
  • Baroreflex sensitivity [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Anne Tikkanen

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

Jeremy Bigalke

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

Locations

Montana State University

Recruiting

Bozeman, Montana, United States, 59717

Contacts

Anne Tikkanen

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

More Information

Sponsor

Montana State University

Last update posted

Oct 7, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montana State University on 2021-10-07.