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Metabolic and Chronobiological Changes in Vestibular Rehabilitation

Primary Purpose

Vestibular Disorder, Metabolic Disease, Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vestibular Rehabilitation
Sponsored by
Uniter Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • ITER Center for Balance and Rehabilitation Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Vestibular Rehabilitation

Delayed Vestibular Rehabilitation

Arm 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

This group will be followed-up for the first month and the it will undergo 4 weeks of vestibular rehabilitation in the second month

Outcomes

Primary Outcome Measures

Fat Mass Percentage
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.
Muscle Mass Percentage
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.
Visceral Fat Level
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 Outcome Measures

Total daily EE (Kcal/day)
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Hours/day spent upright
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Number of strides and distance (Km)
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Daily movement EE (Kcal/day)
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate.
EE (Kcal/min)
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).
sleep onset latency (minutes)
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.
total sleep time (minutes)
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.
wake time after sleep onset (minutes)
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.
sleep efficiency (percentage)
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.

Full Information

First Posted
December 10, 2021
Last Updated
December 28, 2021
Sponsor
Uniter Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT05174104
Brief Title
Metabolic and Chronobiological Changes in Vestibular Rehabilitation
Official Title
Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uniter Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Metabolic Disease, Sleep Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Vestibular Rehabilitation
Arm Type
Experimental
Arm 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
Arm Title
Delayed Vestibular Rehabilitation
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Fat Mass Percentage
Description
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.
Time Frame
one month
Title
Muscle Mass Percentage
Description
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.
Time Frame
one month
Title
Visceral Fat Level
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Total daily EE (Kcal/day)
Description
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Time Frame
one month
Title
Hours/day spent upright
Description
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Time Frame
one month
Title
Number of strides and distance (Km)
Description
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Time Frame
one month
Title
Daily movement EE (Kcal/day)
Description
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate.
Time Frame
one month
Title
EE (Kcal/min)
Description
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).
Time Frame
one month
Title
sleep onset latency (minutes)
Description
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.
Time Frame
one month
Title
total sleep time (minutes)
Description
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.
Time Frame
one month
Title
wake time after sleep onset (minutes)
Description
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.
Time Frame
one month
Title
sleep efficiency (percentage)
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
ITER Center for Balance and Rehabilitation Research
City
Guidonia
State/Province
Rome
ZIP/Postal Code
00012
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Metabolic and Chronobiological Changes in Vestibular Rehabilitation

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