NC Testing in LC & POTS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Calgary
About this trial
Patients with Postural Orthostatic Tachycardia Syndrome (POTS) and Post-Acute Sequelae of COVID (PASC, or "Long COVID") experience cognitive dysfunction. The investigators will test the hypothesis that 999 mL of IV saline will improve cognitive function in patients with POTS and Long COVID compared to placebo (50 mL of saline).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with diagnosis of Long COVID
SARS-COV2 test positive
Symptoms > 12 weeks post COVID
Subjective complaint of 'brain fog" or cognitive dysfunction
Disqualifiers
Patients with overt causes for POTS (e.g., dehydration, prolonged bed rest)
An inability to safely withdraw from medicine(s) that could make test interpretation difficult and impossible.
Other factors which are in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule.
Unable to give an informed consent.
Trial design
Design model
Crossover
Treatments tested in this trial
IV normal saline (999 mL infusion)
Other intervention999 mL of IV normal saline will be infused intravenously
IV normal saline (50 mL infusion)
Other intervention50 mL of IV normal saline will be infused intravenously as a placebo control.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: 999 mL normal SalineExperimental treatment 1 intervention
Group B: 50 mL normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
5RTI Reaction Time task (Standing)
5RTI Reaction Time Score (Standing) after 999 mL IV saline compared to 5RTI score after 50 mL IV saline measured in milliseconds (ms). The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.
Time frame
During Procedure (3 hours)Secondary outcomes
1
Reaction Time Test (Psychomotor Speed)
Reaction Time Test score after 1500mL IV saline compared to after 50mL IV saline measured in milliseconds. The minimum score is 100 ms and the maximum score is 5100 ms. A longer time is a worse outcome.
Time frame
During Procedure (3 hours)2
Paired Associates Learning (Visual Episodic Memory)
Paired Associates Learning score after 999 mL IV saline compared to after 50 mL IV saline measured in arbitrary units. The minimum score is 0 and the maximum score is 70. A higher score is a worse outcome.
Time frame
During Procedure (3 hours)3
Verbal Recognition Memory (Verbal memory)
Verbal Recognition Memory test score after 999 mL IV saline compared to after 50 mL IV saline. The range is 0-18. A higher score is a better outcome.
Time frame
During Procedure (3 hours)4
Multitasking Test (Executive Function - Inhibition)
Multitasking Test Time after 999 mL IV saline compared to after 50 mL IV saline measured in ms. The range is 100 - 2000 ms. A longer time is a worse is a worse outcome.
Time frame
During Procedure (3 hours)Other outcomes
1
Sitting heart rate
Sitting heart rate after 999 mL IV saline compared to after 50 mL IV saline.
Time frame
During Procedure (10 minutes)2
Standing heart rate
Standing heart rate after 999 mL IV saline compared to after 50 mL IV saline.
Time frame
During Procedure (10 minutes)Sponsors and contacts
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Source ClinicalTrials.gov