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

Effects of Hypocapnia on Postural Standing Balance Measured by Sharpened Romberg Testing (SRT) in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Hypocapnia; Balance; Distorted
• Intervention / Treatment: Behavioral: Increased breathing; Other: sharpened Romberg test (SRT)

Detailed Description

The effects of hypocapnia on the postural system have not previously been adequately investigated. The specific aim of this study is to evaluate the effects of hypocapnia on postural standing balance using the sharpened Romberg test (SRT). There is very little research in this area, even though there is significant clinical relevance, ranging from individuals with conditions affecting ventilation (respiratory conditions, cardiac conditions, concussions, medications, post-surgical states requiring ventilatory support etc). The design of the experiment consists of testing healthy subjects and measuring their standing balance with SRT before and after they deliberately lower their carbon dioxide levels by increased ventilation over 2min. End-tidal CO2 (ETCO2) will be used to estimate the blood carbon dioxide level during the experimental procedures. ETCO2 will be measured using the Masimo, Emma Capnometer device. The device is a measurement tool that reads the end tidal carbon dioxide level on its display. The results will then be compared to the normal pre-hypocapnic SRT to assess how hypocapnia affects standing balance.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normocapnic SRT, Hypocapnic SRT, Recovery SRT; Sharpened Romberg Test	Behavioral: Increased breathing; hyperventilation to lower ETCO2; Other: sharpened Romberg test (SRT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to step out from sharpened Romberg test	measurement of time	approximately 10min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capnic status	measurement of ETCO2 with capnometer	approximately 3 minutes

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jan Stepanek, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: balance; hypocapnia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypocapnia
• Other Study ID Numbers: 20-012481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No