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

Primary Purpose

POST-Covid 19, Anxiety

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Application of CES via ear clips

Sham: No application of CES via ear clips

About this trial

This is an interventional treatment trial for POST-Covid 19 focused on measuring Long-Covid/ Post-Covid, CES, fatigue, insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinikum Berchtesgadener Land, Schön Kliniken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Post-Covid patients, anxious, functional device

Post-Covid patients, anxious, Sham

Post-Covid patients, non anxious, functional device

Post-Covid patients, non anxious, Sham

Arm Description

Applitation of 100µA CES for one hour per day to anxious patients

Use of Sham CES for one hour per day by anxious patients

Application of 100µA CES for one hour per day to non anxious patients

Use of Sham CES for one hour per day by non anxious patients

Outcomes

Primary Outcome Measures

Change of symptoms of anxiety during intervention

Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation

Secondary Outcome Measures

Change in insomnia during intervention

Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation

Change in fatigue during intervention

Comparison of the FAS questionnaire pre and post pulmonary rehabilitation

Change in depression during intervention

Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation

Change of general condition/ perceived well-being of the patient

Evaluation of the diary kept by the patient

Subjective effectiveness of device

Evaluation of the diary kept by the patient

Comfort while using the device

Evaluation of the diary kept by the patient

Full Information

NCT ID

NCT05126511

First Posted

November 17, 2021

Last Updated

January 11, 2023

Sponsor

Schön Klinik Berchtesgadener Land

1. Study Identification

Unique Protocol Identification Number

NCT05126511

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

November 19, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Schön Klinik Berchtesgadener Land

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

POST-Covid 19, Anxiety

Keywords

Long-Covid/ Post-Covid, CES, fatigue, insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Post-Covid patients, anxious, functional device

Arm Type

Active Comparator

Arm Description

Applitation of 100µA CES for one hour per day to anxious patients

Arm Title

Post-Covid patients, anxious, Sham

Arm Type

Placebo Comparator

Arm Description

Use of Sham CES for one hour per day by anxious patients

Arm Title

Post-Covid patients, non anxious, functional device

Arm Type

Active Comparator

Arm Description

Application of 100µA CES for one hour per day to non anxious patients

Arm Title

Post-Covid patients, non anxious, Sham

Arm Type

Placebo Comparator

Arm Description

Use of Sham CES for one hour per day by non anxious patients

Intervention Type

Device

Intervention Name(s)

Application of CES via ear clips

Intervention Description

Use of 100µA CES for one hour per day over PR program

Intervention Type

Device

Intervention Name(s)

Sham: No application of CES via ear clips

Intervention Description

Use of Sham CES for one hour per day over PR programm

Primary Outcome Measure Information:

Title

Change of symptoms of anxiety during intervention

Description

Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation

Time Frame

Day 1 and Day 21

Secondary Outcome Measure Information:

Title

Change in insomnia during intervention

Description

Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation

Time Frame

Day 1 and Day 21

Title

Change in fatigue during intervention

Description

Comparison of the FAS questionnaire pre and post pulmonary rehabilitation

Time Frame

Day 1 and Day 21

Title

Change in depression during intervention

Description

Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation

Time Frame

Day 1 and Day 21

Title

Change of general condition/ perceived well-being of the patient

Description

Evaluation of the diary kept by the patient

Time Frame

Day 1 until Day 21

Title

Subjective effectiveness of device

Description

Evaluation of the diary kept by the patient

Time Frame

Day 21

Title

Comfort while using the device

Description

Evaluation of the diary kept by the patient

Time Frame

Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Klinikum Berchtesgadener Land, Schön Kliniken

City

Schönau Am Königssee

State/Province

Bavaria

ZIP/Postal Code

83471

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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