Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of cranial electrotherapy stimulation (CES), for one hour a day over 3 weeks pulmonary rehabilitation (PR) program on symptoms of anxiety in post-Covid patients.

Detailed Description
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Many patients recovering from Covid-19 develop sequelae related to the disease. In addition to lung issues, symptoms of Post-Covid/Long-Covid Syndrome include fatigue, brain fog, amyosthenia, insomnia, anxiety and depression. These symptoms play a major role in post-Covid patients recovery. CES (Cranial electrotherapy stimulation) is a non-invasive therapy using low intensity alternating current applied through electrodes attached to the ear lobe. CES has been used to improve the condition of non covid patients suffering from depression, anxiety, fatigue and cognitive disabilities. This is thought to be due to a change in electric waves of the brain with an increase of alpha-waves and a decrease of beta- and delta-waves, as well as a change of concentration of neurotransmitters, e.g. beta-endorphin or serotonin. Therefore, this study aims to investigate the effect of CES in addition to normal PR, compared to PR alone on symptoms (e.g. anxiety) in post-Covid patients. Hypothesis: Three weeks of PR including daily use of CES for one hour will have a positive effect on symptoms of anxiety. Trial: 40 patients post-Covid reffered to inpatient PR will be recruited and allocated to one of two different groups. Group1: Anxious participants, Group 2: Non anxious participants. Within groups particpants will be randomized to intervention or control/sham. Intervention group will be using a functional device, and the other using a non-functional, SHAM device. Anxiety is evaluated using the Beck anxiety inventory on admission and at discharge from PR. Questionnaires to evaluate fatigue, depression and insomnia are the Fatigue Assessment Scale, PHQ-9, PSQI). A diary will be kept by each participant with a log of general health and mood over the PR program.

Official Title
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Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study

Conditions
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POST-Covid 19, Anxiety

Intervention / Treatment
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* Device: Application of CES via ear clips
* Device: Sham: No application of CES via ear clips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group with anxiety: high Beck Anxiety Inventory Score ≥18 years post SARS-CoV-2 infection written consent Group without anxiety: low Beck Anxiety Inventory Score ≥18 years post SARS-CoV-2 infection written consent Exclusion Criteria: acitve implants (cardiac pacemaker,...) pregnancy, lactation period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Post-Covid patients, anxious, functional device<br>Applitation of 100µA CES for one hour per day to anxious patients | Device: Application of CES via ear clips<br>* Use of 100µA CES for one hour per day over PR program<br>|
| Placebo Comparator: Post-Covid patients, anxious, Sham<br>Use of Sham CES for one hour per day by anxious patients | Device: Sham: No application of CES via ear clips<br>* Use of Sham CES for one hour per day over PR programm<br>|
| Active Comparator: Post-Covid patients, non anxious, functional device<br>Application of 100µA CES for one hour per day to non anxious patients | Device: Application of CES via ear clips<br>* Use of 100µA CES for one hour per day over PR program<br>|
| Placebo Comparator: Post-Covid patients, non anxious, Sham<br>Use of Sham CES for one hour per day by non anxious patients | Device: Sham: No application of CES via ear clips<br>* Use of Sham CES for one hour per day over PR programm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of symptoms of anxiety during intervention | Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation | Day 1 and Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia during intervention | Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation | Day 1 and Day 21 | 
| Change in fatigue during intervention | Comparison of the FAS questionnaire pre and post pulmonary rehabilitation | Day 1 and Day 21 | 
| Change in depression during intervention | Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation | Day 1 and Day 21 | 
| Change of general condition/ perceived well-being of the patient | Evaluation of the diary kept by the patient | Day 1 until Day 21 | 
| Subjective effectiveness of device | Evaluation of the diary kept by the patient | Day 21 | 
| Comfort while using the device | Evaluation of the diary kept by the patient | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-Covid/ Post-Covid, CES, fatigue, insomnia