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Completed

NCT Number: NCT05174104

Metabolic and Chronobiological Changes in Vestibular Rehabilitation

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

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Key information

Conditions

Vestibular Disorder Ear Diseases Labyrinth Diseases Mental Disorders Metabolic Disease Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders Vestibular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ITER Center for Balance and Rehabilitation Research

Guidonia, Rome, 00012, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vestibular Rehabilitation

Procedure

The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day

Primary outcomes

  1. Fat Mass Percentage

    Time frame: one month

    Fat mass percentage will be calculated by using single-frequency BIA with eight-point tactile electrodes (Omron HBF-500 BIA, Omron Medizintechnik, Mannheim, Germany), whose reliability with DXA and MRI measurements was previously demonstrated will be used. This device uses an AC of 500 µA with a single frequency of 50 kHz and eight electrodes in a tetrapolar arrangement, requiring the subject to stand on metal footpads in bare feet and grasp a pair of electrodes fxed on a handle, with arms extended in front of the chest.

  2. Muscle Mass Percentage

    Time frame: one month

    Muscle mass percentage will be calculated by using single-frequency BIA with eight-point tactile electrodes (Omron HBF-500 BIA, Omron Medizintechnik, Mannheim, Germany), whose reliability with DXA and MRI measurements was previously demonstrated will be used. This device uses an AC of 500 µA with a single frequency of 50 kHz and eight electrodes in a tetrapolar arrangement, requiring the subject to stand on metal footpads in bare feet and grasp a pair of electrodes fxed on a handle, with arms extended in front of the chest.

  3. Visceral Fat Level

    Time frame: one month

    Visceral fat level will be calculated by using single-frequency BIA with eight-point tactile electrodes (Omron HBF-500 BIA, Omron Medizintechnik, Mannheim, Germany), whose reliability with DXA and MRI measurements was previously demonstrated will be used. This device uses an AC of 500 µA with a single frequency of 50 kHz and eight electrodes in a tetrapolar arrangement, requiring the subject to stand on metal footpads in bare feet and grasp a pair of electrodes fxed on a handle, with arms extended in front of the chest.

Secondary outcomes

  1. Total daily EE (Kcal/day)

    Time frame: one month

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.

  2. Hours/day spent upright

    Time frame: one month

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.

  3. Number of strides and distance (Km)

    Time frame: one month

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.

  4. Daily movement EE (Kcal/day)

    Time frame: one month

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate.

  5. EE (Kcal/min)

    Time frame: one month

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate this outocome in four targeted conditions (typing, loading the dishwasher, sweeping and walking upstairs and downstairs).

  6. sleep onset latency (minutes)

    Time frame: one month

    Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.

  7. total sleep time (minutes)

    Time frame: one month

    Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.

  8. wake time after sleep onset (minutes)

    Time frame: one month

    Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.

  9. sleep efficiency (percentage)

    Time frame: one month

    Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.

Sponsors and collaborators

Lead sponsor

Uniter Onlus

Other

Registry information

Official study title

Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2021
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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