Skip to main content

Table 1 Participant timeline

From: Transmyringeal ventilation tube insertion for unilateral Menière’s disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial

 

Study period

Enrolment

Allocation

Post-allocation

Close-out

Timepoint

-t1

0

t1

t2

t3

t4

t5

tx

Enrolment

 Eligibility screen

X

       

 Informed consent

X

       

 Allocation

 

X

      

Interventions

 Ventilation tube insertion

 

X

      

 Sham-treatment

 

X

      

Assessments

 Subjective symptom score-schemea

 

X

X

X

X

   

 AAO-HNS functional level scale

 

X

  

X

X

X

 

 Pure-tone and speech audiometry

 

X

  

X

   
  1. Timeline:
  2. t1: At one month
  3. t2: At two months
  4. t3: At three months
  5. t4: At three to six months from t3
  6. t5: At three to six months from t4
  7. t6: At three to six months from t5
  8. t7: At three to six months from t6
  9. t8: At three to six months from t7
  10. t9: At three to six months from t8
  11. aPatients will be asked to fulfill a weekly subjective symptom score-scheme regarding dizziness, tinnitus, hearing and aural fullness.
Back to article page

Trials

ISSN: 1745-6215