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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05126511
Other study ID # AlphaStim
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2021
Est. completion date March 31, 2022

Study information

Verified date January 2023
Source Schön Klinik Berchtesgadener Land
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm

Locations

Country Name City State
Germany Klinikum Berchtesgadener Land, Schön Kliniken Schönau Am Königssee Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of symptoms of anxiety during intervention Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation Day 1 and Day 21
Secondary Change in insomnia during intervention Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation Day 1 and Day 21
Secondary Change in fatigue during intervention Comparison of the FAS questionnaire pre and post pulmonary rehabilitation Day 1 and Day 21
Secondary Change in depression during intervention Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation Day 1 and Day 21
Secondary Change of general condition/ perceived well-being of the patient Evaluation of the diary kept by the patient Day 1 until Day 21
Secondary Subjective effectiveness of device Evaluation of the diary kept by the patient Day 21
Secondary Comfort while using the device Evaluation of the diary kept by the patient Day 21
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