Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05914207 |
| Other study ID # |
MECID.No 2023224-12175 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Malaya |
| Contact |
Jeyasakthy Saniasiaya, MD, MMED ORL |
| Phone |
0126841223 |
| Email |
jeyasakthy[@]um.edu.my |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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
