Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
Primary Purpose
Chronic Insomnia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Insomnia
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
Sites / Locations
- Montana State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug (Suvorexant)
Placebo
Arm Description
20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)
20 mg of Placebo daily (taken orally ~1 hour before bedtime)
Outcomes
Primary Outcome Measures
Sympathetic nerve activity
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
Baroreflex sensitivity
The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
Secondary Outcome Measures
Sympathetic reactivity
The change in muscle sympathetic nerve activity during a cold pressor test.
Home sleep quality: Wrist actigraphy
Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.
Laboratory sleep quality: Polysomnography
Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.
Full Information
NCT ID
NCT03768713
First Posted
December 5, 2018
Last Updated
October 5, 2021
Sponsor
Montana State University
Collaborators
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03768713
Brief Title
Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montana State University
Collaborators
University of Chicago
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug (Suvorexant)
Arm Type
Experimental
Arm Description
20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 mg of Placebo daily (taken orally ~1 hour before bedtime)
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Intervention Description
Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.
Primary Outcome Measure Information:
Title
Sympathetic nerve activity
Description
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
Time Frame
8 weeks
Title
Baroreflex sensitivity
Description
The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Sympathetic reactivity
Description
The change in muscle sympathetic nerve activity during a cold pressor test.
Time Frame
8 weeks
Title
Home sleep quality: Wrist actigraphy
Description
Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.
Time Frame
8 weeks
Title
Laboratory sleep quality: Polysomnography
Description
Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Tikkanen
Phone
406-994-2292
Email
anne.tikkanen@montana.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Bigalke
Phone
406-994-2292
Email
jeremy.bigalke@student.montana.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Carter, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59717
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Tikkanen
Phone
406-994-2292
Email
anne.tikkanen@montana.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
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