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

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ClinicalTrials.gov Identifier: NCT04897360
Recruitment Status : Completed
First Posted : May 21, 2021
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Jan Stepanek, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypocapnia Balance; Distorted Behavioral: Increased breathing Other: sharpened Romberg test (SRT) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of Hypocapnia on Postural Standing Balance Measured by Sharpened Romberg Testing (SRT) in Healthy Subjects
Actual Study Start Date : May 17, 2021
Actual Primary Completion Date : January 1, 2023
Actual Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to step out from sharpened Romberg test [ Time Frame: approximately 10min ]
    measurement of time


Secondary Outcome Measures :
  1. Capnic status [ Time Frame: approximately 3 minutes ]
    measurement of ETCO2 with capnometer


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04897360


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jan Stepanek, MD, MPH Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Jan Stepanek, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04897360    
Other Study ID Numbers: 20-012481
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jan Stepanek, Mayo Clinic:
hypocapnia
balance
Additional relevant MeSH terms:
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Hypocapnia
Signs and Symptoms, Respiratory