ClinicalTrials.Veeva

Menu

Metabolic and Chronobiological Changes in Vestibular Rehabilitation

U

Uniter Onlus

Status

Completed

Conditions

Sleep Disorder
Metabolic Disease
Vestibular Disorder

Treatments

Procedure: Vestibular Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05174104
UniterVestib

Details and patient eligibility

About

The aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means of bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinical validated scales

Full description

Recent advances in the field of vestibular-related disorders demonstrated that such conditions may interfere on different pathways underpinning metabolic behaviour, daily life activities and also chronotype behaviour. However, no studies evaluated how vestibular rehabilitation procedures - well established in literature - may interfere on these vestibular-related disorders. On the other side, recent advances in portable bioelectrical impedenzometry devices, smart watches devised to evaluate energy expenditure during daily life activities and actigraphy devices demonstrated to be useful in continuously monitoring different aspects of metabolic, activity and sleep behaviour.

Thus, the aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinically validated scales

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • unilateral vestibular hypofunction achieved according to accepted criteria, by bithermal caloric irrigation, showing at least 25% reduced vestibular response on one side when calculated by means of Jongkees' formula, 3 months or later after symptom onset. In order to avoid confounding factors, and following previous experiences, only subjects presenting with a concurrent reduction in vestibulo-ocular reflex (VOR) gain when studied by means of video head impulse test will be included in this study.

Exclusion criteria

  • History of falls, cardiovascular, metabolic, rheumatologic, orthopedic, or other neurological conditions, liver or renal abnormalities.
  • pregnancy or breastfeeding.
  • Neurological and neuro-psychiatric diseases
  • insulin-dependent diabetes, vitamin deficiencies, hypothyroidism, lung diseases, hepatitis, chronic kidney failure, and Cushing syndrome
  • medication possibly impacting on cochleo-vestibular function or with a history of drug or alcohol addiction
  • inability to understand and agree to the examination procedures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Early Vestibular Rehabilitation
Experimental group
Description:
This group will undergo a 4 weeks of vestibular rehabilitation in the first month and then it will be only followed up in the second month
Treatment:
Procedure: Vestibular Rehabilitation
Delayed Vestibular Rehabilitation
Experimental group
Description:
This group will be followed-up for the first month and the it will undergo 4 weeks of vestibular rehabilitation in the second month
Treatment:
Procedure: Vestibular Rehabilitation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems