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

Sponsor
Schön Klinik Berchtesgadener Land (Other)
Overall Status
Recruiting
CT.gov ID
NCT05126511
Collaborator
(none)
40
1
4
4.3
9.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Application of CES via ear clips
  • Device: Sham: No application of CES via ear clips
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
Actual Study Start Date :
Nov 19, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Post-Covid patients, anxious, functional device

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

Device: Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program

Placebo Comparator: Post-Covid patients, anxious, Sham

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

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

Active Comparator: Post-Covid patients, non anxious, functional device

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

Device: Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program

Placebo Comparator: Post-Covid patients, non anxious, Sham

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

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

Outcome Measures

Primary Outcome Measures

  1. Change of symptoms of anxiety during intervention [Day 1 and Day 21]

    Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation

Secondary Outcome Measures

  1. Change in insomnia during intervention [Day 1 and Day 21]

    Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation

  2. Change in fatigue during intervention [Day 1 and Day 21]

    Comparison of the FAS questionnaire pre and post pulmonary rehabilitation

  3. Change in depression during intervention [Day 1 and Day 21]

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

  4. Change of general condition/ perceived well-being of the patient [Day 1 until Day 21]

    Evaluation of the diary kept by the patient

  5. Subjective effectiveness of device [Day 21]

    Evaluation of the diary kept by the patient

  6. Comfort while using the device [Day 21]

    Evaluation of the diary kept by the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinikum Berchtesgadener Land, Schön Kliniken Schönau Am Königssee Bavaria Germany 83471

Sponsors and Collaborators

  • Schön Klinik Berchtesgadener Land

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Andreas Rembert Koczulla, Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier:
NCT05126511
Other Study ID Numbers:
  • AlphaStim
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Dr. Andreas Rembert Koczulla, Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land, Schön Klinik Berchtesgadener Land
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021