NCT05126511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

November 17, 2021

Last Update Submit

January 11, 2023

Conditions

POST-Covid 19Anxiety

Keywords

Long-Covid/ Post-CovidCESfatigueinsomnia

Outcome Measures

Primary Outcomes (1)

  • Change of symptoms of anxiety during intervention

    Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation

    Day 1 and Day 21

Secondary Outcomes (6)

  • Change in insomnia during intervention

    Day 1 and Day 21

  • Change in fatigue during intervention

    Day 1 and Day 21

  • Change in depression during intervention

    Day 1 and Day 21

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

    Day 1 until Day 21

  • Subjective effectiveness of device

    Day 21

  • +1 more secondary outcomes

Study Arms (4)

Post-Covid patients, anxious, functional device

ACTIVE COMPARATOR

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

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

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

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

Device: Sham: No application of CES via ear clips

Interventions

Application of CES via ear clipsDEVICE

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

Post-Covid patients, anxious, functional devicePost-Covid patients, non anxious, functional device
Sham: No application of CES via ear clipsDEVICE

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

Post-Covid patients, anxious, ShamPost-Covid patients, non anxious, Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • acitve implants (cardiac pacemaker,...)
  • pregnancy, lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

Location

MeSH Terms

Conditions

Anxiety DisordersFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land

Study Record Dates

First Submitted

November 17, 2021

First Posted

November 19, 2021

Study Start

November 19, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

DE(1)