Vestibular DisorderNCT05174104

Metabolic and Chronobiological Changes in Vestibular Rehabilitation

A study testing Vestibular Rehabilitation in people with Vestibular Disorder and Metabolic Disease, run by Uniter Onlus at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Vestibular Disorder, Metabolic Disease, Sleep Disorder
What is being tested?: Vestibular Rehabilitation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteItaly
Study dates: 1 Mar 2020to 1 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Italy1 site

ITER Center for Balance and Rehabilitation Research
Guidonia, Rome, 00012

Other trials in Italy

About this study

Official title: Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior

Read the 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

Conditions: Vestibular Disorder, Metabolic Disease, Sleep Disorder
Being tested: Vestibular Rehabilitation
Medical subject headings: Vestibular Diseases, Metabolic Diseases, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vestibular RehabilitationProcedure or surgery
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

Study groups in NCT05174104
Study group	Role	What they receive
Early Vestibular Rehabilitation	Experimental	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 Receives: Procedure: Vestibular Rehabilitation
Delayed Vestibular Rehabilitation	Experimental	This group will be followed-up for the first month and the it will undergo 4 weeks of vestibular rehabilitation in the second month Receives: Procedure: Vestibular Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: one month
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.
Measured: one month
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.
Measured: one month

Secondary outcomes (9)

Total daily EE (Kcal/day)
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Measured: one month
Hours/day spent upright
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Measured: one month
Number of strides and distance (Km)
The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.
Measured: one month
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.
Measured: one month
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).
Measured: one month
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.
Measured: one month
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.
Measured: one month
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.
Measured: one month
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.
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20201 Dec 2021

First posted30 Dec 2021
Study start1 Mar 2020
Primary completion1 Mar 2021
Study completion1 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Vestibular DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05174104
Sponsor's protocol ID: UniterVestib
Status last verified: Dec 2021
First submitted: 10 Dec 2021
Last updated: 30 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Herdman SJ, Blatt PJ, Schubert MC. Vestibular rehabilitation of patients with vestibular hypofunction or with benign paroxysmal positional vertigo. Curr Opin Neurol. 2000 Feb;13(1):39-43. doi: 10.1097/00019052-200002000-00008.
PubMed 10719648
Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.
PubMed 34864777
Micarelli A, Viziano A, Pistillo R, Granito I, Micarelli B, Alessandrini M. Sleep Performance and Chronotype Behavior in Unilateral Vestibular Hypofunction. Laryngoscope. 2021 Oct;131(10):2341-2347. doi: 10.1002/lary.29719. Epub 2021 Jun 30.
PubMed 34191310
Micarelli A, Viziano A, Micarelli B, Augimeri I, Alessandrini M. Vestibular rehabilitation in older adults with and without mild cognitive impairment: Effects of virtual reality using a head-mounted display. Arch Gerontol Geriatr. 2019 Jul-Aug;83:246-256. doi: 10.1016/j.archger.2019.05.008. Epub 2019 May 10.
PubMed 31102927
Alessandrini M, Viziano A, Pistillo R, Granito I, Basso L, Preziosi N, Micarelli A. Changes in daily energy expenditure and movement behavior in unilateral vestibular hypofunction: Relationships with neuro-otological parameters. J Clin Neurosci. 2021 Sep;91:200-208. doi: 10.1016/j.jocn.2021.07.012. Epub 2021 Jul 17.
PubMed 34373028
Micarelli A, Viziano A, Granito I, Micarelli RX, Felicioni A, Alessandrini M. Changes in body composition in unilateral vestibular hypofunction: relationships between bioelectrical impedance analysis and neuro-otological parameters. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2603-2611. doi: 10.1007/s00405-020-06561-z. Epub 2021 Jan 3.
PubMed 33392761
Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.
PubMed 28723718
McKeown J, McGeoch PD, Grieve DJ. The influence of vestibular stimulation on metabolism and body composition. Diabet Med. 2020 Jan;37(1):20-28. doi: 10.1111/dme.14166. Epub 2019 Nov 8.
PubMed 31667892
Fuller PM, Jones TA, Jones SM, Fuller CA; New Collective Author. Neurovestibular modulation of circadian and homeostatic regulation: vestibulohypothalamic connection? Proc Natl Acad Sci U S A. 2002 Nov 26;99(24):15723-8. doi: 10.1073/pnas.242251499. Epub 2002 Nov 14.
PubMed 12434016
McGeoch PD. Can Vestibular Stimulation be Used to Treat Obesity?: Vestibular stimulation targeting the otoliths could rebalance energy homeostasis to trigger a leaner body habitus and thus treat metabolic syndrome. Bioessays. 2019 Feb;41(2):e1800197. doi: 10.1002/bies.201800197. Epub 2019 Jan 7.
PubMed 30614540
Fuller PM, Jones TA, Jones SM, Fuller CA; New Collective Author. Evidence for macular gravity receptor modulation of hypothalamic, limbic and autonomic nuclei. Neuroscience. 2004;129(2):461-71. doi: 10.1016/j.neuroscience.2004.05.059.
PubMed 15501603
Tighilet B, Chabbert C. Adult neurogenesis promotes balance recovery after vestibular loss. Prog Neurobiol. 2019 Mar;174:28-35. doi: 10.1016/j.pneurobio.2019.01.001. Epub 2019 Jan 15.
PubMed 30658127

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior
ClinicalTrials.gov ID: NCT05174104
Acronym / sponsor ID: UniterVestib
Conditions: Vestibular Disorder, Metabolic Disease, Sleep Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Uniter OnlusUniversity, hospital or other
Study start: 1 Mar 2020 (actual)
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Dec 2021 (actual)
First posted: 30 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early Vestibular Rehabilitation	Experimental	Procedure: Vestibular RehabilitationThis 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
Delayed Vestibular Rehabilitation	Experimental	Procedure: Vestibular RehabilitationThis group will be followed-up for the first month and the it will undergo 4 weeks of vestibular rehabilitation in the second month

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vestibular RehabilitationThe 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	Procedure or surgery	Delayed Vestibular Rehabilitation, Early Vestibular Rehabilitation

Primary outcome

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.
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.
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.

9 secondary outcomes

Total daily EE (Kcal/day)
Time frame: one month
Hours/day spent upright
Time frame: one month
Number of strides and distance (Km)
Time frame: one month
Daily movement EE (Kcal/day)
Time frame: one month
EE (Kcal/min)
Time frame: one month
sleep onset latency (minutes)
Time frame: one month
total sleep time (minutes)
Time frame: one month
wake time after sleep onset (minutes)
Time frame: one month
sleep efficiency (percentage)
Time frame: one month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
Background: PubMed 10719648Herdman SJ, Blatt PJ, Schubert MC. Vestibular rehabilitation of patients with vestibular hypofunction or with benign paroxysmal positional vertigo. Curr Opin Neurol. 2000 Feb;13(1):39-43. doi: 10.1097/00019052-200002000-00008.
Background: PubMed 34864777Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.
Background: PubMed 34191310Micarelli A, Viziano A, Pistillo R, Granito I, Micarelli B, Alessandrini M. Sleep Performance and Chronotype Behavior in Unilateral Vestibular Hypofunction. Laryngoscope. 2021 Oct;131(10):2341-2347. doi: 10.1002/lary.29719. Epub 2021 Jun 30.
Background: PubMed 31102927Micarelli A, Viziano A, Micarelli B, Augimeri I, Alessandrini M. Vestibular rehabilitation in older adults with and without mild cognitive impairment: Effects of virtual reality using a head-mounted display. Arch Gerontol Geriatr. 2019 Jul-Aug;83:246-256. doi: 10.1016/j.archger.2019.05.008. Epub 2019 May 10.
Background: PubMed 34373028Alessandrini M, Viziano A, Pistillo R, Granito I, Basso L, Preziosi N, Micarelli A. Changes in daily energy expenditure and movement behavior in unilateral vestibular hypofunction: Relationships with neuro-otological parameters. J Clin Neurosci. 2021 Sep;91:200-208. doi: 10.1016/j.jocn.2021.07.012. Epub 2021 Jul 17.
Background: PubMed 33392761Micarelli A, Viziano A, Granito I, Micarelli RX, Felicioni A, Alessandrini M. Changes in body composition in unilateral vestibular hypofunction: relationships between bioelectrical impedance analysis and neuro-otological parameters. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2603-2611. doi: 10.1007/s00405-020-06561-z. Epub 2021 Jan 3.
Background: PubMed 28723718Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.
Background: PubMed 31667892McKeown J, McGeoch PD, Grieve DJ. The influence of vestibular stimulation on metabolism and body composition. Diabet Med. 2020 Jan;37(1):20-28. doi: 10.1111/dme.14166. Epub 2019 Nov 8.
Background: PubMed 12434016Fuller PM, Jones TA, Jones SM, Fuller CA; New Collective Author. Neurovestibular modulation of circadian and homeostatic regulation: vestibulohypothalamic connection? Proc Natl Acad Sci U S A. 2002 Nov 26;99(24):15723-8. doi: 10.1073/pnas.242251499. Epub 2002 Nov 14.
Background: PubMed 30614540McGeoch PD. Can Vestibular Stimulation be Used to Treat Obesity?: Vestibular stimulation targeting the otoliths could rebalance energy homeostasis to trigger a leaner body habitus and thus treat metabolic syndrome. Bioessays. 2019 Feb;41(2):e1800197. doi: 10.1002/bies.201800197. Epub 2019 Jan 7.
Background: PubMed 15501603Fuller PM, Jones TA, Jones SM, Fuller CA; New Collective Author. Evidence for macular gravity receptor modulation of hypothalamic, limbic and autonomic nuclei. Neuroscience. 2004;129(2):461-71. doi: 10.1016/j.neuroscience.2004.05.059.
Background: PubMed 30658127Tighilet B, Chabbert C. Adult neurogenesis promotes balance recovery after vestibular loss. Prog Neurobiol. 2019 Mar;174:28-35. doi: 10.1016/j.pneurobio.2019.01.001. Epub 2019 Jan 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vestibular Rehabilitation in people with Vestibular Disorder and Metabolic Disease, run by Uniter Onlus at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat Mass Percentage (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174104, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.