Yang 2020.

Study name	A prospective study on the treatment of patients with sudden deafness and diabetes with two different ways of administration
Methods	Prospective, non‐blinded, parallel‐group randomised superiority trial
Participants	Inclusion criteria: 1) aged 18 to 65 years old; 2) a sudden onset of sensorineural hearing loss within 72 hours, at least in the 3 consecutive frequency of hearing loss of ≥ 30 dB HL; 3) unilateral onset; 4) confirmed diabetes; 5) the time of onset is within 30 days; 6) hearing loss must have been deemed idiopathic
Interventions	Group I (n = 43): 4 x 1 mL doses of 40 mg/mL of methylprednisolone over a 1‐week period, with a dose administered every 2 days via tympanic membrane injection into the middle ear Group II (n = 43): intravenous methylprednisolone (1 mg/kg/day, maximal dose 60 mg/day) for 5 days
Outcomes	Primary outcome is the change in hearing threshold from the first audiogram to the 30‐day follow‐up audiogram Secondary outcome measures will include pure tone average (PTA) at 90‐day follow‐up, visual analogue tinnitus scale, visual analogue vertigo scale, visual analogue aural fullness scale, fasting blood glucose and 2‐hour postprandial blood glucose during treatment and the change in glycosylated haemoglobin (HbA1C) levels. Vital signs and otological physical examination will be performed at each follow‐up visit.
Starting date	Planned study execute time: 1 January 2018 to 31 December 2022
Contact information	Weiqiang Yang, Peking Unversity Shenzhen hospital, 1120 Lianhua Road, Futian District, Shenzhen, Guangdong, China, e‐mail: 497450210@qq.com
Notes	ChiCTR, ChiCTR1800015954 Registered on 2 May 2018, retrospectively registered

DHI: Dizziness Handicap Inventory; THI: Tinnitus Handicap Inventory; VEMP: vestibular evoked myogenic potential