EDC for red light and photobiomodulation studies where the dose has to be reported

Photobiomodulation (PBM), often marketed as red light or low-level light therapy, applies red or near-infrared light to tissue, and studies range from oral mucositis and musculoskeletal pain to skin and cognitive outcomes. Across that literature, one criticism recurs: papers that do not report the parameters cannot be compared or pooled. Commonly recommended items are the wavelength, the irradiance (power per unit area), the fluence or energy density (irradiance multiplied by time), the treatment area, any pulsing, and the timing and number of sessions. Dosimetry reporting recommendations from the laser-therapy community exist, and you should check the current version against your own protocol.

That literature shapes the build. Do not bury dose in a notes field. Create a session form with a dropdown or numeric field for each parameter, store the planned values in the protocol, and record the delivered values per session. A calculated field can show fluence from irradiance and time read-only at entry, like Capture's other derived fields, so a mis-keyed duration is visible immediately. Where the device itself sets the output, record the programme or setting code and keep the physical specification in the device documentation.

Studies range from supervised clinic sessions to home-use panels used daily. In a home design, the participant logs each session on their phone as a short ePRO diary, and staff review the adherence by site. See digital patient diary software for the diary model and epro compliance reminders by SMS and email for reminder structure. Treat self-reported home sessions as a different quality of exposure data than a staff-run clinic session, and record which kind each row is.

Many light devices on the consumer market are sold as general wellness products, while some are cleared for narrow, device-specific indications. Which category your device is in changes what regulators and ethics boards expect, whether an investigational device application is needed, and what claims you can make. Check the device label and current regulator guidance; this page does not state any device's status. The broader device pathway is described in EDC for medical device clinical trials and early feasibility and pivotal device study EDC.

Safety is usually low-risk, and still needs structure. Eye protection, skin warmth or redness, headaches and interactions with photosensitizing medicines are commonly considered. Capture the protocol-defined events on the session form and the standard adverse event form, and record eye-protection use as a field if the protocol requires it. Every change carries a field-level audit trail.

If sleep is an outcome or an explanatory variable, the study team can enable the native Oura connection per study, mark it required, and have each participant connect their own account; data syncs automatically with a visible last-sync time. It is context for your analysis. No other wearable is claimed. See EDC for wearable device studies and the wearable data sharing consent template.