POST-Covid 19NCT05126511
Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19
A study testing Application of CES via ear clips in people with POST-Covid 19 and Anxiety, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- POST-Covid 19, Anxiety
- What is being tested?
- Application of CES via ear clips
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 19 Nov 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group with anxiety:
- high Beck Anxiety Inventory Score
- ≥18 years
- post SARS-CoV-2 infection
- written consent
- Group without anxiety:
Show all 10Show fewer
- low Beck Anxiety Inventory Score
- ≥18 years
- post SARS-CoV-2 infection
- written consent
Who cannot join
- acitve implants (cardiac pacemaker,...)
- pregnancy, lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, Bavaria, 83471
About this study
Official title: Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
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.
Read the 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.
- Conditions
- POST-Covid 19, Anxiety
- Being tested
- Application of CES via ear clips, Sham: No application of CES via ear clips
- Keywords
- Long-Covid/ Post-Covid, CES, fatigue, insomnia
- Medical subject headings
- Anxiety Disorders, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of CES via ear clipsDevice
Use of 100µA CES for one hour per day over PR program
Sham: No application of CES via ear clipsDevice
Use of Sham CES for one hour per day over PR programm
| Study group | Role | What they receive |
|---|---|---|
| Post-Covid patients, anxious, functional device | Active comparator | Applitation of 100µA CES for one hour per day to anxious patients Receives: Device: Application of CES via ear clips |
| Post-Covid patients, anxious, Sham | Placebo comparator | Use of Sham CES for one hour per day by anxious patients Receives: Device: Sham: No application of CES via ear clips |
| Post-Covid patients, non anxious, functional device | Active comparator | Application of 100µA CES for one hour per day to non anxious patients Receives: Device: Application of CES via ear clips |
| Post-Covid patients, non anxious, Sham | Placebo comparator | Use of Sham CES for one hour per day by non anxious patients Receives: Device: Sham: No application of CES via ear clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of symptoms of anxiety during intervention
Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation
Measured: Day 1 and Day 21
Secondary outcomes (6)
Change in insomnia during intervention
Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation
Measured: Day 1 and Day 21
Change in fatigue during intervention
Comparison of the FAS questionnaire pre and post pulmonary rehabilitation
Measured: Day 1 and Day 21
Change in depression during intervention
Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation
Measured: Day 1 and Day 21
Change of general condition/ perceived well-being of the patient
Evaluation of the diary kept by the patient
Measured: Day 1 until Day 21
Subjective effectiveness of device
Evaluation of the diary kept by the patient
Measured: Day 21
Comfort while using the device
Evaluation of the diary kept by the patient
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start19 Nov 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POST-Covid 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126511
- Sponsor's protocol ID
- AlphaStim
- Status last verified
- Jan 2023
- First submitted
- 17 Nov 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05126511
- Acronym / sponsor ID
- AlphaStim
- Conditions
- POST-Covid 19, Anxiety
- Keywords
- Long-Covid/ Post-Covid, CES, fatigue, insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Post-Covid patients, anxious, functional device | Active comparator | Device: Application of CES via ear clipsApplitation of 100µA CES for one hour per day to anxious patients |
| Post-Covid patients, anxious, Sham | Placebo comparator | Device: Sham: No application of CES via ear clipsUse of Sham CES for one hour per day by anxious patients |
| Post-Covid patients, non anxious, functional device | Active comparator | Device: Application of CES via ear clipsApplication of 100µA CES for one hour per day to non anxious patients |
| Post-Covid patients, non anxious, Sham | Placebo comparator | Device: Sham: No application of CES via ear clipsUse of Sham CES for one hour per day by non anxious patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- high Beck Anxiety Inventory Score
- ≥18 years
- post SARS-CoV-2 infection
- written consent
- low Beck Anxiety Inventory Score
Key exclusion criteria (2 listed)
- acitve implants (cardiac pacemaker,...)
- pregnancy, lactation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of CES via ear clipsUse of 100µA CES for one hour per day over PR program | Device | Post-Covid patients, anxious, functional device, Post-Covid patients, non anxious, functional device |
| Sham: No application of CES via ear clipsUse of Sham CES for one hour per day over PR programm | Device | Post-Covid patients, anxious, Sham, Post-Covid patients, non anxious, Sham |
Primary outcome
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
6 secondary outcomes
Change in insomnia during intervention
Time frame: Day 1 and Day 21
Change in fatigue during intervention
Time frame: Day 1 and Day 21
Change in depression during intervention
Time frame: Day 1 and Day 21
Change of general condition/ perceived well-being of the patient
Time frame: Day 1 until Day 21
Subjective effectiveness of device
Time frame: Day 21
Comfort while using the device
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of CES via ear clips in people with POST-Covid 19 and Anxiety, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of symptoms of anxiety during intervention (time frame: Day 1 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.