tVNS in Long COVID-19

Not Applicable

Recruiting

• Conditions: Long COVID; Chronic Fatigue Syndrome

• Registration Number: NCT06585254
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-3
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> - Must have had documented Covid infection and then fulfill 2015 case definition for<br> ME/CFS<br><br> - Chalder Fatigue Scale score of 4 or greater<br><br> - SF-36 Physical Function scale score =70<br><br> - VAS values of 3 or higher from 0 [none] 3 [substantial] to 5 [very severe burden] on<br> at least two of the following symptoms - fatigue; widespread pain, brain fog,<br> post-exertional malaise<br><br>Exclusion Criteria:<br><br> - BMI =30<br><br> - Hospitalized for COVID-19 infection<br><br> - BMI =30<br><br> - Pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Chalder Fatigue Questionnaire (CFQ);Change in Short Form Health Survey (SF-36);Visual Analog Scale (VAS) measuring Fatigue;VAS to measure Widespread Pain;VAS measuring Postexertional malaise (PEM);VAS measuring brain fog;Global Clinical Assessment of Change

Secondary Outcome Measures

Name	Time	Method
Heart Rate Variability