EDC for hyperbaric oxygen therapy studies, from chamber log to symptom score

Hyperbaric oxygen therapy (HBOT) delivers oxygen at a pressure above normal atmospheric pressure in a sealed chamber, usually over a course of daily sessions. Published trials vary widely in how they define the dose: the pressure in atmospheres absolute (ATA), the time at pressure, the number of sessions and the gas breathed. Because the course is often long, a protocol can specify dozens of sessions over several weeks, and the participant is expected to attend nearly all of them. That makes the session record the spine of the dataset.

The obvious data-capture consequence is that exposure is a stream of rows, not a single dispensing event. Each session needs a date, a chamber, a protocol programme code, the time at pressure, whether it finished as planned, and who operated it. If sessions are logged as free text in a spreadsheet, the analysis of adherence and dose received becomes a clean-up project. In Capture, build the session as a repeating eCRF form with required fields and edit checks, so a missing duration or an impossible date raises an auto-query at entry.

Published sham-controlled hyperbaric trials have used air or low-oxygen mixes at a low pressure, with a simulated pressurization and depressurization so participants feel something happen. Whether a given sham is credible is a design and biology question for the protocol team. A recent volunteer study even tested whether the minimum workable pressure could blind people to a higher active exposure. Capture does not decide that for you. What it does is keep the allocation out of reach of anyone who should not see it, which is the data-system half of keeping the blind.

Meta-analyses of randomized hyperbaric trials have reported more adverse effects with hyperbaric oxygen than with control, with ear discomfort or barotrauma the most frequent, claustrophobia the next, and the rate rising with higher pressure and longer courses. Exact rates differ between reviews and populations, so treat any number as a planning input to be confirmed against current literature, not a promise. The data-capture point is that mild, expected events happen at high frequency in a long course, and the protocol should say which of them are recorded as adverse events and which only as session tolerability notes.

Build both. A per-session tolerability field is fast for the chamber attendant to complete, and a protocol-defined threshold (for example, anything moderate or worse, or anything causing a missed session) can create an adverse event record using the standard adverse event form. Edit checks can raise a query when a session is marked stopped early but no reason or event is recorded. Pre-treatment checks that your protocol requires, such as ear examination or contraindication screening, belong on a physical exam form or the screening form, and the clinical decision to proceed with a session remains with the clinical team.

Every change carries a field-level audit trail with timestamp, user, old value, new value and reason, and the trail cannot be edited. That matters in long courses, where a corrected session duration weeks later has to be traceable. Query handling is described on the query management page.

Hyperbaric trials in neurological, wound-healing or wellness settings measure outcomes that do not need the chamber: pain, sleep, fatigue, mood, cognition or function. Participant-reported measures can run as ePRO tasks opened from a link in the phone browser, with reminders you set, so there is no app to install. See BYOD ePRO with no app download. Sleep structure is a common secondary outcome, and the structure of a sleep instrument is shown on the PSQI template page. Template pages show structure and scoring only, and you remain responsible for any instrument licence.

If sleep or recovery context matters, the study team can enable the native Oura connection per study, mark it required, and participants connect their own account; data then syncs with a last-sync time visible. It is wearable context for your analysis, not a clinical measurement of the chamber exposure, and no other device is claimed. A broader view of wearable designs is on EDC for wearable device studies, and a consent template for sharing device data is the wearable data sharing consent template.