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NCT Number: NCT05126511

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

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.

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Key information

Conditions

POST-Covid 19 Anxiety Anxiety Disorders Dyssomnias Fatigue Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of CES via ear clips

Device

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

Sham: No application of CES via ear clips

Device

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

Primary outcomes

  1. Change of symptoms of anxiety during intervention

    Time frame: Day 1 and Day 21

    Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation

Secondary outcomes

  1. Change in insomnia during intervention

    Time frame: Day 1 and Day 21

    Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation

  2. Change in fatigue during intervention

    Time frame: Day 1 and Day 21

    Comparison of the FAS questionnaire pre and post pulmonary rehabilitation

  3. Change in depression during intervention

    Time frame: 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

    Time frame: Day 1 until Day 21

    Evaluation of the diary kept by the patient

  5. Subjective effectiveness of device

    Time frame: Day 21

    Evaluation of the diary kept by the patient

  6. Comfort while using the device

    Time frame: Day 21

    Evaluation of the diary kept by the patient

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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