About the trial

The portal is general-purpose, but it was built for a specific study: the Acoustic Ripple Therapy (ART) tinnitus trial. This page describes that trial so the rest of the manual has a concrete example to point at. Your own trial may differ; the portal supports the same shape of design with different numbers.

The therapy

Participants listen to a personalised therapeutic sound for around 60 minutes a day. The sound is matched to the participant’s hearing and tinnitus (see Audio pipeline in depth), and is modulated in a specific frequency band. The active therapy uses the modulation band intended to help; the sham uses a control band, so the two are indistinguishable to the participant but only one is therapeutic.

The design: a randomised crossover

ART is a randomised, placebo-controlled crossover:

  1. Each participant is randomly allocated to start in either the active or the sham group.

  2. They complete a treatment period (this trial: 6 weeks, roughly 60 minutes of listening per day).

  3. A washout follows (this trial: 3 weeks), during which there is no listening but participants still give a daily tinnitus rating.

  4. They then cross over into the opposite group and repeat the treatment period.

Because every participant experiences both conditions, each person is their own control. Which condition they had at which time is revealed only at the debrief at the very end (see Participants and the trial lifecycle).

Bigger designs

This trial uses two arms and two treatment periods, but the portal supports more: up to several intervention periods with washouts between them, and additional arms. You build that shape in Step 4 · Schema.

What a participant does

  1. Register and consent (a short unlock delay, then the consent form).

  2. Screening to confirm eligibility (see Assessments in depth).

  3. Baseline questionnaires (THI, TFI, IHS).

  4. Hearing profile and tinnitus matching to personalise the sound.

  5. Treatment period 1 with daily listening and before/after ratings.

  6. Washout 1 with daily ratings and washout questionnaires.

  7. Treatment period 2 (the opposite arm) and its ratings.

  8. Final washout, end questionnaires, and debrief.

The chapters that follow explain each of these from the researcher’s side: how you configure them, and what the participant sees.