Clinical trial NCT05174104: Metabolic and Chronobiological Changes in Vestibular Rehabilitation
Official title: Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Metabolic Disease
Sleep Disorder
Lead sponsor: Uniter Onlus
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Fat Mass Percentage
timeFrame: one month
measure: Muscle Mass Percentage
timeFrame: one month
measure: Visceral Fat Level
timeFrame: one month
Secondary outcomes:
measure: Total daily EE (Kcal/day)
timeFrame: one month
measure: Hours/day spent upright
timeFrame: one month
measure: Number of strides and distance (Km)
timeFrame: one month
measure: Daily movement EE (Kcal/day)
timeFrame: one month
measure: EE (Kcal/min)
timeFrame: one month
measure: sleep onset latency (minutes)
timeFrame: one month
measure: total sleep time (minutes)
timeFrame: one month
measure: wake time after sleep onset (minutes)
timeFrame: one month
measure: sleep efficiency (percentage)
timeFrame: one month
Other outcomes:
Locations:
city: Guidonia
country: Italy
facility: ITER Center for Balance and Rehabilitation Research
state: Rome
Study officials:
References:
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