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
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|Condition or disease||Intervention/treatment||Phase|
|Hypocapnia Balance; Distorted||Behavioral: Increased breathing Other: sharpened Romberg test (SRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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|
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.
- Time to step out from sharpened Romberg test [ Time Frame: approximately 10min ]measurement of time
- Capnic status [ Time Frame: approximately 3 minutes ]measurement of ETCO2 with capnometer
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|Ages Eligible for Study:||21 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Research subject conditions that may result in alterations of ventilatory control (capnic status) and balance will be specifically reviewed as criteria for participation.
- 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.
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
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Jan Stepanek, MD, MPH||Mayo Clinic|
|Responsible Party:||Jan Stepanek, Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||May 21, 2021 Key Record Dates|
|Last Update Posted:||January 17, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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