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Vestibular MigraineNCT05914207

Non-Pharmacological Treatment of Vestibular Migraine in Children and Adolescent

A study testing Lifestyle modifications and Vestibular rehabilitation exercise in people with Vestibular Migraine, run by University of Malaya at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Vestibular dysfunction has traditionally been linked to various conditions that affect older adults. Recent studies have shown that children and adolescents suffer from vestibular impairments, yet the numbers are still low due to some factors, including the non-typical presentations. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Vestibular Migraine
What is being tested?
Lifestyle modifications and Vestibular rehabilitation exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMalaysia
Study dates
1 Nov 2023to 1 Dec 2024
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 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children and adolescents between 5-18 years
  • Diagnosed with vestibular migraine based on the Diagnostic criteria consensus document of the Classification Committee of Vestibular Disorders of the Bárány Society and the International Headache Society

Who cannot join

  • Not able to comprehend or able to follow instructions
  • syndromic, other ontological, neurological conditions

Trial locations and contacts

1 site in 1 country.

Jeyasakthy Saniasiaya, MD, MMED ORL contact

0126841223

jeyasakthy@um.edu.my

Malaysia1 site
  • Universiti Malaya Medical Centre

    Kuala Lumpur, 500603

    Jeyasakthy Saniasiaya, MD, MMED ORL, +60126841223, jeyasakthy@um.edu.my

Other trials in Malaysia

About this study

Official title: Effects of Lifestyle Modifications and Vestibular Rehabilitation Therapy in Children and Adolescents With Vestibular Migraine

Vestibular dysfunction has traditionally been linked to various conditions that affect older adults. Recent studies have shown that children and adolescents suffer from vestibular impairments, yet the numbers are still low due to some factors, including the non-typical presentations. Vestibular migraine has been found to be the most common condition of vestibular dysfunction among children and adolescents. Nonetheless, most children remain undiagnosed due to lack awareness and vague clinical presentations. Parallel to that, there has been no consensus regarding the management algorithm. Most children are managed with pharmacological management extrapolated from the adult algorithm. Many clinicians fail to understand that pharmacological treatments are not sustainable long-term and should focus on lifestyle modifications such as sleep and dietary habits and other non-pharmacological treatments such as deep breathing exercises and vestibular rehabilitation therapy. This study aims to investigate the effect of non-pharmacological treatment in managing children and adolescents with VM. The investigators will use a standardised questionnaire before and after interventions to investigate the effect of lifestyle modifications, simple vestibular rehabilitation exercises and deep breathing techniques in children and adolescents with VM. Lifestyle modifications and vestibular rehabilitation exercise is a more sustainable way of managing children and adolescents with VM, avoiding the side effects of medication, and is more cost-effective. If the non-pharmacological treatment shows promising results, the investigators will continue with multicentre randomised-controlled studies.

Read the detailed description

The prevalence of vestibular dysfunction is approximately 30.4% among children and adolescents. Yet, the exact prevalence in children remains a quandary owing to several factors: difficulties describing symptoms and cannot differentiate between true vertigo, unsteadiness, imbalance and light-headedness; secondly, the short-lived nature of some peripheral vestibular conditions results in early and rapid compensation; thirdly, nuanced clinical manifestations of vestibular as well as balance impairment accounts for it being overlooked finally, lack of specialists to manage children with vestibular impairment.

Vestibular dysfunction or impairment results in disturbance in the body's balance system. Nonetheless, the most common symptoms include vertigo, nausea, vomiting, intolerance to head motion, nystagmus, unsteady gait, and postural instability. Although clinical presentation may be mild, vestibular dysfunction may impact the quality of life and day-to-day activity, especially school activities such as reading and learning, which are vital for these age groups.

Vestibular loss affects cognitive and emotional disturbance related to reflexive deficits, which are related to the role of ascending vestibular pathway to the limbic system and the neocortex's role in the sense of spatial orientation. Vestibular and balance impairment amongst adolescents and young adults will, in the long term, affect social, emotional, psychological and quality of life as vestibular and balance function is imperative in day-to-day life and activity.

Vestibular migraine (VM) is found to be the most common cause of dizziness among children and adolescents. The exact prevalence of VM remains unknown as VM is still underdiagnosed due to a lack of awareness amongst parents and attending physicians. It is worth noting that the diagnosis of VM in children and adolescents has traditionally been based on the description of clinical symptoms by the patient or parents/caretaker. The lack of definitive biomarkers and gold-standard diagnostic tools contributes to the delay in diagnosis. The typical battery of investigations, including otological, neurological, ophthalmological, and imaging performed, are oftentimes carried out to rule out other pathological disorders.

Vestibular migraine in children is diagnosed based on diagnostic criteria which recently has been put forth by the Committee for the Classification of Vestibular Disorders of the Bar any Society (ICVD) and the Migraine Classification subgroup of the International Headache Society, which describes the three spectrums of VM: Vestibular Migraine of Childhood, probable Vestibular Migraine of Childhood and Recurrent Vertigo of Childhood specific for children under 18 years of age.

No gold standard investigation tool exists to diagnose VM, as the available investigations are performed mainly to exclude other conditions such as Meniere's disease and BPPV.

Additionally, there is no evidence-based approach for treating VM in children and adolescents, with most recommendations extrapolated from reports on adult and childhood migraine headaches. Only two included studies described medication for VM. Overall, treatment for VM can be divided into pharmacological and non-pharmacological treatment. Pharmacological treatment of VM in children includes those taken during acute attacks and prophylactic treatment. Vestibular suppressants and triptans have been used to abort acute attacks in children and adolescents, although the exact efficacy is still unknown.

Non-pharmacological treatment aimed as a prophylactic measure such as eliminating migraine-triggering diet, vestibular rehabilitation, supplements, and a healthy lifestyle. Triggering factors such as increased screen time and usage of immersive technology needs attention parallel to getting adequate sleep, a healthy diet and breathing exercise. Lifestyle modifications have shown significant improvement among adult patients diagnosed with definite VM. Yet, no studies involving children and adolescents. The investigators aim to conduct a study to investigate the effect of lifestyle modifications, simple home-based vestibular rehabilitation and deep breathing exercise in children and adolescents diagnosed with VM. Lifestyle modifications, vestibular rehabilitation exercise and deep breathing exercise is a more sustainable way of managing children and adolescents with VM, avoids the side effects of medication, and is cost-effective.

Hypothesis The investigators hypothesise that non-pharmacological treatment which involves lifestyle modifications, home-based vestibular rehabilitation therapy and deep relaxation breathing, will be effective in controlling and reducing the symptoms of vestibular migraine in children and adolescents.

Innovation The majority of the studies on pharmacological interventions for vestibular migraine revolve around adult patients. Although the optimal treatment algorithm among adult vestibular migraine remains debatable, the effect of lifestyle modifications in vestibular migraine adult patients has shown promising results. The current research is innovative as the investigators will use an elaborate guide of lifestyle modifications which focuses on the child's dietary, sleep, and lifestyle habits, including increased physical activity, reduction of screen time as well as incorporating simple home-based vestibular rehabilitation therapy and deep breathing exercise. All children and adolescents will be diagnosed with vestibular migraine of childhood according to the Barany Consensus criteria. The investigators will divide the participants into 2 groups: children and adolescents. The investigators believe that the proposed investigation will be a more sustainable way to control, reduce vestibular migraine symptoms, and improve the overall quality of life among the participants. The findings from this research will be the foundation and pave the way for future larger-scale multicentre studies.

Research plan The investigators propose that an elaborate guide to lifestyle modifications focusing on the child's dietary, sleep, lifestyle habits, in addition to simple home-based vestibular rehabilitation therapy and deep breathing exercise, will reduce and improve vestibular symptoms in children and adolescents. No studies on non-pharmacological intervention among children and adolescents with vestibular migraine have been published. Yet, data involving adult patients have shown promising results, although no study involving adult patients with vestibular migraine has looked into the effect of lifestyle modifications which includes dietary and sleep habits, in addition to incorporating vestibular rehabilitation therapy and deep breathing exercise in a single study.

Justification of the study

Lifestyle modifications have successfully prevented Vestibular migraine (VM) in the adult study. No studies involving children and adolescents with VM have been carried out. The investigators aim to conduct a study to investigate the effect of lifestyle modifications and simple vestibular rehabilitation in children and adolescents diagnosed with VM. Lifestyle modifications and vestibular rehabilitation exercise is a more sustainable way of managing children and adolescents with VM, avoiding the side effects of medication and being cost-effective.

It is important to investigate the effects of lifestyle modifications on VM because the underlying causes of vestibular migraine are unclear. Our modifications include food triggers, restful sleep, exercise, eating regularity, vestibular rehabilitation, and deep breathing exercise. The investigators hypothesize comprehensive lifestyle modifications, vestibular rehabilitation, and deep breathing exercise will improve vestibular migraine symptoms. This project is important because vestibular migraine is reported to be one of the most common causes of vertigo, and interventions useful for other migraine types or vestibular symptoms may not be effective for VM in children and adolescents. If the investigators demonstrate improvement with comprehensive lifestyle modifications, the investigators will continue the line of investigation with randomized, controlled studies. This work furthers our goal of helping children and adolescents with VM.

Main Objective To investigate the effects of elaborate lifestyle modifications, vestibular rehabilitation therapy and deep breathing exercise among children and adolescents with vestibular migraine.

Specific Objective

  • To determine the effect of lifestyle modifications, vestibular rehabilitation therapy and deep breathing exercise on the paediatric Dizziness Handicap Inventory (P-DHI)[5-12] and Dizziness Handicap Inventory (DHI) [13-18] pre and post-intervention
  • To determine the effect of lifestyle modifications, vestibular rehabilitation therapy and deep breathing exercise on the overall quality of life pre and post-intervention

Hypothesis Comprehensive lifestyle modifications will improve the self-perceived impact of the symptoms of dizziness and headache in individuals with vestibular migraine.

Study endpoints

To determine the outcome of lifestyle modifications, vestibular rehabilitation and deep breathing exercises in children and adolescents with VM

Methodology

Study Type and Design

Study design: Exploratory Prospective cross-sectional study

  • Duration: 2 years
  • Subjects: Children and Adolescents aged between 5 to 18 years

Study population:

Patients aged between 5-18 years of age attending the Paediatric Vestibular and balance (ENT) clinic

Patients aged between 5 to 18 years old will be screened based on inclusion and exclusion criteria. Once the patient or parent/caretaker consents to participate in the study, the patient will be interviewed to complete a proforma, including the patient's socio-demographic, past medical history, otological, vestibular and balance complaints, and otoscopic examination. The patient, parent/caretaker will fill P-DHI or the DHI questionnaire at the first visit. This will be followed by a hearing assessment with pure tone audiometry and tympanometry, a routine examination for children and adolescents with vestibular symptoms. This will be followed by bedside vestibular assessment with video head impulse test (VHIT), cervical vestibular evoked myogenic potential (cVEMP), and subjective visual vertical (SVV). All test procedures were performed using a non-invasive technique and were explained to all participants before starting.

FLOWCHART

Patients aged 5-18 years fulfill the Barany criteria of VM

Socio-demographic, Otological, Vestibular Screening

  1. st visit P-DHI (5-12yrs) or DHI (13-18) Lifestyle modifications + VRT regime
  2. nd visit 4 weeks, 8 weeks: repeat P-DHI (5-12yrs) or DHI (13-18)

Study Population Children and adolescents aged between 5 to 18 years attending UMMC or in the community, either students in University Malaya or secondary school students in Klang Valley.

Withdrawal Criteria:

Subjects can choose to withdraw at any time. However, it is worth noting that all the investigations included in this study are safe.

Sample Size: 60 (Pilot study) Post-hoc power analysis will be done following data collection

Study Duration and Timeline: 2 years

Being tested
Lifestyle modifications, Vestibular rehabilitation exercise
Keywords
Children, Adolescent, Non-pharmacological, lifestyle modifications, vestibular rehabilitation therapy

What participants receive

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

  • Lifestyle modificationsBehavioural

    Written suggestions on lifestyle modifications including duration of sleep, meal frequency, reduce screen time, exercise duration, food to avoid.

  • Vestibular rehabilitation exerciseOther

    Each participant will be taught simple home-based vestibular rehabilitation exercise, which needs to be repeated

Study groups in NCT05914207
Study groupRoleWhat they receive
Vestibular Migraine groupExperimentalWritten, verbal and pictorial descriptions will be provided for each participant regarding lifestyle modifications and vestibular rehabilitation exercise
Receives: Behavioral: Lifestyle modifications; Other: Vestibular rehabilitation exercise

What is being measured

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

  1. Paediatric Dizziness Handicap Inventory

    This measure assesses impact of dizziness in children between 5-12 years

    Measured: This measure is carried after one month

  2. Dizziness Handicap Inventory

    This measure assesses impact of dizziness in children above 12 -18

    Measured: This measure is carried out after one month

Timeline

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

  1. First posted22 Jun 2023
  2. Study start1 Nov 2023 (estimated)
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Children and adolescents who are diagnosed with Vestibular Migraine
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914207
Sponsor's protocol ID
MECID.No 2023224-12175
Status last verified
Jun 2023
First submitted
8 May 2023
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle modifications and Vestibular rehabilitation exercise in people with Vestibular Migraine, run by University of Malaya at 1 site in Malaysia.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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 Malaysia. 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?

Results are not available in the source record.

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

Contact Jeyasakthy Saniasiaya, MD, MMED ORL (0126841223, jeyasakthy@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paediatric Dizziness Handicap Inventory (time frame: This measure is carried after one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Jun 2023.

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