Atrial fibrillation Atrial fibrillation
Conditions
Interventions
Patients will self-administer infrared irradiation using the Super Lizer mini device once daily for 20 minutes per session (alternating 5 minutes on each side of the neck for two sets). This will cont
Sponsors
Komatsu Yuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient with atrial fibrillation and an implanted device. 2)Patients with at least one episode of atrial fibrillation recorded monthly via remote device monitoring for two months prior to enrollment. 3)Patients deemed capable of understanding and appropriately using the Super Lizer mini device. 4)Patients aged 18 years or older and under 80 years at the time of informed consent. 5)Patients who, after receiving a full explanation of their participation in this study, fully understand and provide written informed consent of their own free will. 6)Outpatients.
Exclusion criteria
Exclusion criteria: 1)Patients with photosensitivity. 2)Patients with sensory impairment in the neck due to severe diabetes or similar conditions. 3)Patients with uncontrolled hypertension. 4)Patients with thyroid masses or other neoplastic lesions in the neck. 5)Patients with tattoos at the irradiation site on the neck. 6)Patients who have undergone sympathetic nerve block procedures. 7)Patients whom the Principal Investigator (or sub-investigator) deems otherwise unsuitable as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total duration of atrial fibrillation per month before and after stellate ganglion phototherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in number of episodes and mean duration of atrial fibrillation per month before and after stellate ganglion phototherapy Change in heart rate. Change in symptoms (e.g., palpitations, shortness of breath, chest discomfort). Presence of skin disorders. Changes in device lead data (threshold, sensing data, pacing rate). Changes in blood test data (IL-6, TNF, catecholamine fractions, white blood cell count, BNP, NPY). Change in Pittsburgh Sleep Quality Index (PSQI). Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Duration and number of episodes of atrial fibrillation one month post-treatment. | — |
Contacts
Public ContactYasutoshi Shinoda
University of Tsukuba Hospital
Outcome results
None listed