Adverse events
tenderness, skin irritation, headaches
Throughout participation, 37 participants reported during study contact and check-in calls that they had discomfort in using the Dreem headband. Dreem discomfort was also reported by 67 participants in the post-intervention questionnaire, including Dreem impacting sleep (e.g. movement due to the loose fit, pressure due to sleep position) and/or causing tenderness or headaches. During the study, modifications were made to address some of these concerns (e.g. using elastic tighteners to improve fit and having breaks between uses); participants were free to discontinue using Dreem if they chose to.Additionally, eight participants reported during study contact and check-in calls, that they had discomfort in using Fitbit. Fitbit discomfort was also reported by nine participants in the post-intervention questionnaire, including lighting on Fitbit disrupting sleep, loose fit, and/or skin irritation. During the study, modifications were made to address these concerns (e.g. providing a smaller Fitbit band, covering the device screen to reduce light); participants were free to discontinue using Fitbit if they chose to.