NCT03768713

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Montana State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Suvorexant	Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.
DRUG	Placebo	Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.

Timeline

• Start date: 2019-04-18
• Primary completion: 2022-12-01
• Completion: 2023-04-01
• First posted: 2018-12-07
• Last updated: 2021-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study