Suspended

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

What is being tested

Suvorexant

+ Placebo

Drug

Who is being recruted

Mental Disorders+3

+ Sleep Initiation and Maintenance Disorders

+ Nervous System Diseases

From 18 to 65 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 4

Interventional

Study Start: April 2019

See protocol details

Summary

Principal SponsorMontana State University

Study ContactAnne TikkanenMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 18, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

NCT03768713

Principal SponsorMontana State University

Study ContactAnne TikkanenMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSleep Initiation and Maintenance DisordersNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

Criteria

4 inclusion criteria required to participate

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)

11 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Placebo

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Montana State University

Bozeman, United StatesOpen Montana State University in Google Maps

SuspendedOne Study Center