Core concepts¶
A handful of terms recur throughout the portal. This page defines them once; later chapters assume them.
Trial structure¶
- Trial
The whole study: its identity, its arms, its phases, the questionnaires, the audio, and the participants. A trial moves through a lifecycle from Draft to Completed (see Participants and the trial lifecycle).
- Arm (treatment)
A distinct condition a participant can be in. There are four kinds:
Active: the therapeutic sound under test.
Sham: a control sound, paired with the active arm it mirrors so blinding works.
Washout (nothing): a rest period with no listening at all.
Washout (unmodulated): a rest period where participants still listen, but to a plain, unmodulated sound.
- Phase
A stage of the trial over time, for example Baseline, an Intervention period, a Washout, and the post-trial Debrief. A trial is a sequence of phases; each intervention/washout phase is filled by an arm.
- Randomisation sequence
The ordering of arms a participant follows. In a parallel trial each participant is placed in one arm and stays there. In a crossover trial every participant passes through all the arms, in a randomised order, each order is a sequence.
Recruitment¶
- Completion target
The number of participants you expect to complete a given arm. It is a soft goal, never a hard cap, an arm may overshoot it. Targets also set how likely a new participant is to be assigned to each arm. See Enrolment and randomisation.
- Estimated completion rate
The fraction of enrolled participants you expect to finish (default 0.5). It turns your completion targets into a total recruitment ceiling.
Questionnaires¶
- Assessment
A questionnaire in the reusable library, its questions, how they are scored, and when they are asked. The same generic system renders every questionnaire in the app.
- Timing
When an assessment is asked, for example before treatment, at the start or end of a treatment period, every day, or at the end of the trial.
Audio¶
- Sound type
The category of therapeutic sound (for example an amplitude-modulated tone).
- Hearing profile
A preset describing a participant’s hearing (for example Mild, Moderate), used to pick the right sound file.
- Modulation band
The frequency band a sound is modulated in (for example 2–4 kHz). An unmodulated sound has no band.
These three together identify each uploaded sound; see Audio pipeline in depth.