NCT04105998

Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)

Effects of Intramuscular Oxytocin on Pupil Diameter and Heart Rate Variability

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to test the effects of oxytocin on heart rate variability and pupil diameter, both of which have subtle effects on the activity rate of the autonomic nervous system.

Detailed description

This protocol focuses on two measures of autonomic control to quantify central actions of oxytocin. First, the study team proposes to examine the influence of oxytocin on heart rate variability with focus on its effect on high frequency variability, most commonly ascribed to parasympathetic nervous system activity acting to brake sympathetic tone. Intranasal oxytocin has been demonstrated to have a large effect size on this measure which can be repeated at frequent intervals. As a secondary assessment of parasympathetic activity, the study team will measure low frequency fluctuation in pupil diameter, termed hippus, which also reflects parasympathetic nervous system activity. This outcome measure can be assessed in 3 seconds using equipment currently being used under Institutional Review Board (IRB) approved protocols.

Conditions

• Chronic Pain Due to Injury

Interventions

Type	Name	Description
DRUG	Oxytocin	Oxytocin 10 IU
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-10-24
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2019-09-26
• Last updated: 2022-11-10
• Results posted: 2022-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study