Design
SECONDARY
The current study is part of phase II exploratory clinical trial. A prospective randomized, double-blind, sham-controlled study was conducted from December 14, 2020, to December 27, 2021, at Shamir Medical Center (SMC), Israel. After signing informed consent, patients were randomized to either HBOT or sham-control groups in a 1:1 ratio according to a computerized randomization table, performed using an in-house software written in MATLAB R2021b (MathWorks, Natick, MA), supervised by a blinded researcher.Patients were questioned after the first session on their perception regarding the treatment they received to evaluate masking. The evaluation procedure was done at baseline and 1–3 weeks after the last HBOT/sham session. All evaluators were blinded to the patients’ group allocations. The study was approved by SMC’s Institutional Review Board (IRB) (No. 332–20-ASF) and all participants signed informed consent before their inclusion. All research was performed according to the relevant guidelines and regulations. This study was registered with ClinicalTrials.gov, number NCT04647656 on 01/12/2020. The primary end point of this clinical trial was cognitive function which was reported in the first publication along with secondary endpoints of the associated related symptoms brain MRI features. This article focused on the cardiac functions evaluated on the same study population.