ClinicalTrials.Veeva
Menu

Comprehensive Evaluation in Patients With Meniere's Disease

H

Hacettepe University

Status

Completed

Conditions

Psychosocial Problem
Meniere Disease
Quality of Life
Physical Disability

Treatments

Other: International physical activity questionnaire-measurement of physical activity level with short
Other: Vertigo symptom scale-short form
Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment
Other: Dizziness disability inventory
Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
Other: Temporomandibular joint range of motion assessment
Other: Dynamic balance assessment with tandem gait test
Other: Tinnitus disability scale
Other: Evaluation of fatigue with the fatigue severity scale
Other: Hearing Impairment Scale
Other: Static balance assessment with tandem stance test
Other: A feeling of fullness and/or pressure in the ear
Other: Posture evaluation with New York posture analysis
Other: Evaluation of quality of life with short form-12 (SF-12)
Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale
Other: Case report form
Other: Evaluation of postural balance with the Freemed pressure platform
Other: assessment of muscle performance
Other: Evaluation of the anterior tilt angle of the head
Other: Cervical Range of Motion (CROM 3) device
Other: Dizziness intensity and frequency
Other: Evaluation of sleep quality with the Pittsburgh sleep quality index
Other: the International Fall Efficiency Scale

Study type

Observational

Funder types

Other

Identifiers

NCT05844657
Hacettepe Universitey

Details and patient eligibility

About

The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.

Full description

Meniere's disease (MD) is an inner ear disease characterized by independent attacks and lasting for at least 20 minutes, dizziness, recurrent hearing loss during seizures, tinnitus, fullness in the ear, and a feeling of headache. After the diagnosis of the disease, the most disturbing situation for the patient is the uncertainty of the progression of the disease and the deterioration of the quality of life. It is very difficult to know and predict how the disease will progress. Quality of life is impaired by current symptoms and may be further reduced by uncertainty about when another attack may occur and activity restriction due to fear of provoking symptoms with exertion or stress.

When the studies on MD are examined, it is seen that the symptoms affect not only certain physical conditions but also psychological conditions. It has been observed that psychological factors play a more important role than is commonly realized in terms of their impact on patients' quality of life. MD has a negative impact on the person's daily life, and the person avoids certain daily activities or situations because of the illness. Looking at the literature, it is not known whether the severity of disease symptoms or whether the psychological state precedes the physical state.

In light of all this information, MD appears to be a multifaceted condition that can have major and often alarming effects on the lives of affected individuals. Therefore, it is important to evaluate individuals with MD with a holistic approach.

The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.

Read more

Enrollment

34 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Study group Inclusion Criteria:

  • Having been diagnosed with Meniere's disease as a result of clinical and audiological evaluation by an ENT specialist
  • ability to read and write
  • be between the ages of 18-65
  • Not having an acute attack and not receiving acute attack treatment during the study period,
  • Having given consent to participate in the study as a result of the information
  • A minimum score of 24 on the Mini Mental Test (MMDT)

Study group Exclusion Criteria:

  • Known neurological disease (head trauma, spinal trauma, multiple sclerosis, intracranial tumor, etc.) Having an anatomical problem or disease related to the outer and middle ear
  • Peripheral and central vestibular pathology other than Meniere's disease
  • Sensorineural hearing loss due to other causes
  • Other neurological, orthopedic, circulatory system or vision problems that may cause vertigo, dizziness and balance disorder

Control group Inclusion Criteria:

  • ability to read and write
  • be between the ages of 18-65
  • Not having an acute attack and not receiving acute attack treatment during the study period,
  • Having given consent to participate in the study as a result of the information
  • A minimum score of 24 on the Mini Mental Test (MMDT)
  • without vertigo

Control group Exclusion Criteria:

  • suffering from vertigo
  • Known neurological disease (head trauma, spinal trauma, multiple sclerosis, intracranial tumor, etc.) Having an anatomical problem or disease related to the outer and middle ear
  • Peripheral and central vestibular pathology other than Meniere's disease
  • Sensorineural hearing loss due to other causes
  • Other neurological, orthopedic, circulatory system or vision problems that may cause vertigo, dizziness and balance disorder

Trial design

34 participants in 2 patient groups

Individuals with Meniere's disease
Description:
Voluntary Meniere's patients aged 18-65 years, not in the relapse period, who met the inclusion criteria
Treatment:
Other: Static balance assessment with tandem stance test
Other: assessment of muscle performance
Other: Evaluation of sleep quality with the Pittsburgh sleep quality index
Other: Evaluation of postural balance with the Freemed pressure platform
Other: Evaluation of the anterior tilt angle of the head
Other: Cervical Range of Motion (CROM 3) device
Other: Dizziness intensity and frequency
Other: Dizziness disability inventory
Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale
Other: Vertigo symptom scale-short form
Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment
Other: the International Fall Efficiency Scale
Other: International physical activity questionnaire-measurement of physical activity level with short
Other: Tinnitus disability scale
Other: Evaluation of fatigue with the fatigue severity scale
Other: Dynamic balance assessment with tandem gait test
Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
Other: Temporomandibular joint range of motion assessment
Other: Evaluation of quality of life with short form-12 (SF-12)
Other: Posture evaluation with New York posture analysis
Other: A feeling of fullness and/or pressure in the ear
Other: Case report form
Other: Hearing Impairment Scale
Healthy individuals without Meniere's disease
Description:
Volunteer healthy individuals aged 18-65 years without dizziness who met the inclusion criteria
Treatment:
Other: Static balance assessment with tandem stance test
Other: assessment of muscle performance
Other: Evaluation of sleep quality with the Pittsburgh sleep quality index
Other: Evaluation of postural balance with the Freemed pressure platform
Other: Evaluation of the anterior tilt angle of the head
Other: Cervical Range of Motion (CROM 3) device
Other: Dizziness intensity and frequency
Other: Dizziness disability inventory
Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale
Other: Vertigo symptom scale-short form
Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment
Other: the International Fall Efficiency Scale
Other: International physical activity questionnaire-measurement of physical activity level with short
Other: Tinnitus disability scale
Other: Evaluation of fatigue with the fatigue severity scale
Other: Dynamic balance assessment with tandem gait test
Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
Other: Temporomandibular joint range of motion assessment
Other: Evaluation of quality of life with short form-12 (SF-12)
Other: Posture evaluation with New York posture analysis
Other: A feeling of fullness and/or pressure in the ear
Other: Case report form
Other: Hearing Impairment Scale

Trial contacts and locations

1

Loading...

Central trial contact

Nezire Kose, 2; Gülistan Örenç, 1

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Research sites

Find research sitesLearn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy NoticeTerms
© Copyright 2025 Veeva Systems