#DIZZINESS HANDICAP INVENTORY TRIAL#

#DIZZINESS HANDICAP INVENTORY TRIAL#

Pharmacy staff will be unblinded for randomization and treatment allocation.Įmergency unblinding may occur in the following situations: in case of a medical emergency where knowledge of the blinded treatment is necessary, for the treatment of (serious) adverse event, in the event of a SUSAR (Suspected Unexpected Serious Adverse Reaction) needing expedited reporting or if requested by the Safety Committee.Ī Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial). Trial subjects, treating physicians and outcome assessors will be blinded throughout the entire study. Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More InformationĪ multicenter, double-blinded, randomized, placebo-controlled trial The primary objective will be the control of vertigo, with secondary outcomes including hearing loss, tinnitus, the frequency of escape interventions, quality of life, adverse events and cost effectiveness. A follow-up visit will be scheduled after six and twelve months and telephone follow-up calls will be scheduled after three and nine months. After 14 days, this injection will be given once more. Patients will be randomly randomized to one of the two treatment arms, receiving either a placebo injection or a methylprednisolone sodium succinate injection at a dose of 62.5 mg/ml. The investigators aim to include 74 patients in each arm, based on a statistical power of 80 percent. Therefore in this double-blinded, randomized, placebo-controlled trial, effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENière's disease is compared. Methylprednisolone injections have been shown to be safer, however there is insufficient data to support the efficacy of this treatment.

A probable effectiveness of the treatment with intratympanic gentamicin is found but this treatment is ototoxic and carries a risk of hearing loss. Salt restriction, oral medication (diuretics and betahistine), intratympanic gentamicin and steroids, ablative surgery, and endolymphatic sac surgery are some of the current therapy options. Endolymfactic hydrops is thought to be the underlying pathophysiology of the symptoms. It is estimated that 15000 patients in de Netherlands suffer from this disease. Meniere's disease is an inner ear disease characterized by recurrent episodes of vertigo, hearing loss, tinnitus and aural fullness. Why Should I Register and Submit Results?.Adding an index of depression, as measured by the PHQ-9, increased the adjusted R to 64% (p < 0.0001).ĭHI score variability is explained by mental health and quality-of-life measures in addition to the daily burden of dizziness. Additional factors, including the number of dizzy days per month, the number of dizziness descriptors (spinning, lightheadedness, disequilibrium, etc.), and the number of dizziness triggers (loud sounds, stress, riding in a car, etc.), were all significantly associated with higher DHI scores a multiple linear regression model showed that these three aforementioned factors combined accounted for 56% of the variability in the DHI scores (p < 0.0001). Several validated quality of life and mental health survey scores (SF-36-quality of life PHQ-9-depression and GAD-7-anxiety) were significantly correlated with higher DHI scores. We performed univariate analyses on numerous demographic and dizziness-related factors, and constructed a multivariate model based on explaining the highest variance in the data with the least number of independent variables. Seventy subjects were included in our study. Our goal was to investigate the key demographic and symptom-related factors to that account for DHI variance.Īdult patients presenting to a dizziness clinic.ĭHI variance explained by multiple linear regression. However, there is wide variability in scores, and little is known about which variables contribute to dizziness-related quality of life.

The Dizziness Handicap Inventory (DHI) is the most commonly used quality of life measure for vestibular disorders.

Dizziness handicap inventory