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

Chronic Insomnia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03768713
• Other study ID #: JC101320-FC
• Status: Recruiting
• Phase: Phase 4
• Start date: April 18, 2019
• Est. completion date: April 2023

Study information

• Verified date: October 2021
• Source: Montana State University
• Contact: Anne Tikkanen
• Phone: 406-994-2292
• Email: anne.tikkanen[@]montana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Montana State University	University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathetic nerve activity	Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.	8 weeks
Primary	Baroreflex sensitivity	The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.	8 weeks
Secondary	Sympathetic reactivity	The change in muscle sympathetic nerve activity during a cold pressor test.	8 weeks
Secondary	Home sleep quality: Wrist actigraphy	Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.	8 weeks
Secondary	Laboratory sleep quality: Polysomnography	Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.	8 week