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

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Mayo Clinic

Status

Completed

Conditions

Balance; Distorted
Hypocapnia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04897360
20-012481

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

20 participants in 1 patient group

Normocapnic SRT, Hypocapnic SRT, Recovery SRT
Experimental group
Description:
Sharpened Romberg Test
Treatment:
Other: sharpened Romberg test (SRT)
Behavioral: Increased breathing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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