A Study to Evaluate the Effects of Sharpened Romberg Testing (SRT) in Healthy Subjects

NCT04897360 | Completed

• 1 other identifier: 20-012481
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being done to evaluate the effectiveness of using the sharpened Romberg test to screen for impaired postural control in patients with impaired or altered breathing patterns.

Conditions

Hypocapnia; Balance; Distorted

Keywords

hypocapnia; balance

Outcome Measures

Primary Outcomes (1)

• Time to step out from sharpened Romberg test

  measurement of time

  approximately 10min

Secondary Outcomes (1)

• Capnic status

  approximately 3 minutes

Study Arms (1)

Normocapnic SRT, Hypocapnic SRT, Recovery SRT

EXPERIMENTAL

Sharpened Romberg Test

Behavioral: Increased breathing; Other: sharpened Romberg test (SRT)

Interventions

Increased breathing BEHAVIORAL

hyperventilation to lower ETCO2

Normocapnic SRT, Hypocapnic SRT, Recovery SRT

sharpened Romberg test (SRT) OTHER

Balance test conducted by standing with feet in front of each other, heel-to-toe in line while the right hand is on the left shoulder and the left hand is on the right shoulder.

Normocapnic SRT, Hypocapnic SRT, Recovery SRT

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Research subject conditions that may result in alterations of ventilatory control (capnic status) and balance will be specifically reviewed as criteria for participation.

You may not qualify if:

• Current pregnancy in women, alcohol use within the past 3 days prior to the experiment, history of balance problems (e.g., vertigo, neuropathy, central or peripheral vestibular disorders), and musculoskeletal disorders affecting the ability to perform a SRT in participants.
• Patients currently taking carbonic anhydrase inhibitors, opioids, benzodiazepines, hypnotics, first-generation H1 antihistamines, amphetamines, and first-generation antipsychotics.
• Patients with a history of insomnia, sleep apnea, circadian rhythm disturbances, narcolepsy, movement disorders, chronic low blood pressure, fainting spells, multiple concussions, seizure disorders, migraines, severe headaches and panic attacks.
• If the patient took medications known to cause prolonged QTc interval and other cardiac arrhythmias, the researchers will exclude the patient from the study.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypocapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Stepanek, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 21, 2021
• Study Start: May 17, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (1)