2.1. Study Design
sleep disturbance
The study was a pilot randomized, parallel-group, double-blind, and sham-controlled trial on the effects of FIR energy on sleep disturbance using specially designed pajamas. Informed consent was obtained before all study procedures. Subjects were randomly assigned to the FIR-emitting pajamas (FIR pajamas) group or the sham-pajamas control group in a 1:1 ratio. Ethics approval was obtained from the local ethic review board (HSEARS20201109005). The trial was registered on ClinicalTrials.gov (ClinicalTrials.gov identifier: #NCT04890002), and all the study procedures followed the protocol in the register. This RCT was conducted and reported following CONSORT recommendations.