NC Testing in LC & POTS

NCT05914649 | Recruiting

• 1 other identifier: REB23-0202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postural Orthostatic Tachycardia Syndrome; Post Acute Sequelae of SARS CoV 2 Infection

Keywords

POTS; Long COVID; Cognitive; Brain Fog

Outcome Measures

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.

  During Procedure (3 hours)

Secondary Outcomes (4)

• Reaction Time Test (Psychomotor Speed)

  During Procedure (3 hours)

• Paired Associates Learning (Visual Episodic Memory)

  During Procedure (3 hours)

• Verbal Recognition Memory (Verbal memory)

  During Procedure (3 hours)

• Multitasking Test (Executive Function - Inhibition)

  During Procedure (3 hours)

Other Outcomes (2)

• Sitting heart rate

  During Procedure (10 minutes)

• Standing heart rate

  During Procedure (10 minutes)

Study Arms (2)

999 mL normal Saline

EXPERIMENTAL

999 mL of normal saline infused intravenously.

Other: IV normal saline (999 mL infusion)

50 mL normal Saline

PLACEBO COMPARATOR

50 mL of normal saline infused intravenously.

Other: IV normal saline (50 mL infusion)

Interventions

IV normal saline (999 mL infusion) OTHER

999 mL of IV normal saline will be infused intravenously

999 mL normal Saline

IV normal saline (50 mL infusion) OTHER

50 mL of IV normal saline will be infused intravenously as a placebo control.

50 mL normal Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with diagnosis of Long COVID
• SARS-COV2 test positive
• Symptoms \> 12 weeks post COVID
• Subjective complaint of 'brain fog" or cognitive dysfunction
• Patients with diagnosis of Postural Orthostatic Syndrome (POTS) from the Calgary Autonomic Investigation and Management Clinic
• Subjective complaint of 'brain fog" or cognitive impairment
• Healthy participants
• Without POTS or "brain fog"
• Age 18 to 60 years
• Female and Male
• Able to give an informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Post-Acute COVID-19 Syndrome; Mental Fatigue

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Satish R Raj, MD MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish R Raj, MD MSCI

CONTACT

(403)210-6152; autonomic.research@ucalgary.ca

Rasha Hamzeh, RN

CONTACT

autonomic.research@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the person administering the cognitive testing will be blinded to the volume of saline infused (999 mL or 50 mL).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete both the active and placebo arms of the study in a random order.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: September 19, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)