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

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ClinicalTrials.gov Identifier: NCT03768713
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Michigan Technological University

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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: Suvorexant Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Suvorexant (Belsomra®) on Sympathetic Neural Activity and Baroreflex Function in Patients With Chronic Insomnia
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arm Intervention/treatment
Experimental: Drug (Suvorexant)
20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)
Drug: Suvorexant
Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.

Placebo Comparator: Placebo
20 mg of Placebo daily (taken orally ~1 hour before bedtime)
Drug: Placebo
Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.




Primary Outcome Measures :
  1. Sympathetic nerve activity [ Time Frame: 8 weeks ]
    Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.

  2. Baroreflex sensitivity [ Time Frame: 8 weeks ]
    The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.


Secondary Outcome Measures :
  1. Sympathetic reactivity [ Time Frame: 8 weeks ]
    The change in muscle sympathetic nerve activity during a cold pressor test.

  2. Home sleep quality: Wrist actigraphy [ Time Frame: 8 weeks ]
    Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.

  3. Laboratory sleep quality: Polysomnography [ Time Frame: 8 week ]
    Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum 3 months of clinically diagnosed insomnia
  • Body mass index ≤35 kg/m2
  • Insomnia Severity Index (ISI) > 14 arbitrary units (i.e., moderate-to-severe insomnia)
  • Pittsburgh Sleep Quality Index (PSQI) > 5 arbitrary units
  • Habitual self-report and objectively-assessed (i.e., 14-day actigraphy) sleep duration of <6.5 hours
  • 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 > 15 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 ≥ 10 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), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics), beta blockers, or alpha blockers
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768713


Contacts
Contact: Anne Tikkanen (Michigan Tech Location) 906-487-2711 altikkan@mtu.edu
Contact: Soumia Msallek (U Chicago Location) 773-702-1234 smsallek@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Babak Mokhlesi, MD         
United States, Michigan
Michigan Technological University Not yet recruiting
Houghton, Michigan, United States, 49931
Contact: Jason R Carter, PhD         
Sponsors and Collaborators
Michigan Technological University
University of Chicago
Investigators
Principal Investigator: Jason Carter, PhD Michigan Technological University
Principal Investigator: Babak Mokhlesi, MD University of Chicago

Responsible Party: Michigan Technological University
ClinicalTrials.gov Identifier: NCT03768713     History of Changes
Other Study ID Numbers: M1703
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Suvorexant
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs