Reference¶
Quick lookups that support the rest of the manual.
Trial statuses¶
- Draft
Being built in the setup wizard; not visible to participants.
- Recruiting
Live and accepting participants.
- Not recruiting (recruitment closed)
Live but no longer accepting participants, either the completion target was reached (permanent) or the enrolment limit paused it (may resume).
- Completed
Finished.
Participant statuses¶
Status |
Meaning |
Counts toward enrolment limit? |
Counts toward completion target? |
|---|---|---|---|
Registered / waiting to unlock |
Signed up, not yet started |
Yes |
No |
Active |
Currently taking part |
Yes |
No |
Completed |
Finished the trial |
Yes |
Yes |
Withdrawn |
Left or removed |
No (frees a place) |
No |
Assessment timings¶
Timing |
When it is asked |
|---|---|
At enrolment |
Eligibility screening |
Before treatment |
Baseline measures |
Start of each treatment period |
At the start of each intervention phase |
End of each treatment period |
At the end of each intervention phase |
Before each daily session |
Before a listening session |
After each daily session |
After a listening session |
Every day |
A daily check-in |
End of trial |
The final questionnaire |
Arm types¶
Type |
Listening |
Purpose |
|---|---|---|
Active |
Therapeutic sound |
The intervention under test |
Sham |
Control sound |
Blinded comparison, paired to an active arm |
Washout (nothing) |
None |
A rest period with no listening |
Washout (unmodulated) |
Plain sound |
A rest period with non-therapeutic listening |
Recruitment terms¶
Term |
Definition |
|---|---|
Participants to complete (per arm) |
Soft goal of completers for an arm; sets its randomisation share |
Estimated completion rate |
Fraction expected to finish (0 to 1) |
Total completion target |
Sum of per-arm targets; the irreversible stop |
Total enrolment limit |
Total completion target ÷ rate, rounded up; the reversible pause |
Architecture diagrams¶
The tinnitus-api repository holds architecture diagrams under docs/architecture/
(participant journey, trial-setup journey, data model, audio-assignment decision, and
more). These can be embedded here as the manual grows; they are the authoritative
picture of how the system fits together.