Ear-Zapping device shows promise for lupus fatigue

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Reading and understanding Danish. * SLE diagnosis based on SLE disease classification criteria for at least 1 year. * Stable disease and medication the past 28 days as defined by: * No change in disease modifying antirheumatic drugs or biological therapy, * Receiving maximally 10 mg prednisone daily. * Having signs of fatigue, as assessed by scoring ≤ 40 in the FACIT-Fatigue questionnaire. * Having signs of autonomic dysfunction, as assessed by scoring one or more of: 1. VAGUS score ≥1 2. SUDOSCAN score \< 50µS for hands or \< 70µS for feet 3. COMPASS-31 score \> 12 * Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures. * Sign the dated informed consent documents Exclusion criteria * Significant cardiovascular disease, including congenital cardiac disease, congestive heart failure, known severe coronary artery disease, or recent myocardial infarction (within 5 years), as assessed by a physician at the screening. * Blood pressure \< 100/60 or \> 160/105 * Clinically significant bradycardia or tachycardia * History of abnormal baseline ECG, prolonged QT interval or arrhythmia * Previous surgery on the vagus nerve or abnormal cervical anatomy * Implanted or portable electro-mechanical medical devices, e.g. pacemaker, defibrillator, cochlear implant and infusion pump * Metallic device such as a stent, bone plate or bone screw implanted at or near the neck * Receiving active laser treatment for proliferative retinopathy * Active cancer or cancer in remission * History of brain tumor, aneurysm, bleed, head trauma, clinically significant syncope or seizures * Any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. * Participation in other clinical trials less than three months prior to inclusion, unless such a participation is judged to have no influence on the recordings * Female pregnancy (positive urine-HCG), ongoing lactation or intended pregnancy during the study period. * A pregnancy test is conducted at first and last visit to ensure that fertile female patients are not pregnant during the study period. * Further, the investigator ensures that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study period. Safe contraception: The combined oral contraceptive pill; intra uterine device; gestagen injection; subdermal implantation; hormone vaginal ring; and transdermal plaster. * Male patients who intend to father a child during the course of the study