Meniere DiseaseNCT05844657
Comprehensive Evaluation in Patients With Meniere's Disease
An observational study of Meniere Disease and Psychosocial Problem, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniere Disease, Psychosocial Problem, Physical Disability
- What is being tested?
- Case report form, Tinnitus disability scale and A feeling of fullness and/or pressure in the ear
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 4 Oct 2023
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with Meniere's disease and people with without Meniere's disease
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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe Sağlık Bilimleri Enatitüsü
Ankara, 06000
About this study
Official title: Investigation of the Physical and Psychosocial Status and Quality of Life of People With Meniere's Disease
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 the detailed 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.
- Being tested
- Case report form, Tinnitus disability scale, A feeling of fullness and/or pressure in the ear, Dizziness intensity and frequency, Dizziness disability inventory
- Keywords
- Meniere's disease, postural balance, posture, vertigo, tinnitus, proprioception, quality of life
- Medical subject headings
- Meniere Disease, Vertigo, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case report formOther
Sociodemographic information (age, gender, height, body mass index, marital status, occupation, education level, contact information), frequency of smoking and alcohol use, frequency of caffeine consumption, frequency of salt consumption, dominant side, background, family history, medical and audiological information were recorded.
Tinnitus disability scaleOther
Tinnitus disability scale was used to evaluate the tinnitus severity of Meniere's patients. It consists of 25 items in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Tinnitus level or severity is determined by calculating the total score of the answers given.
A feeling of fullness and/or pressure in the earOther
The feeling of fullness or pressure in the ear was evaluated verbally by receiving yes/no responses from the participants.
Dizziness intensity and frequencyOther
In order to determine the frequency and severity of dizziness, the participants were asked to mark the appropriate score between 1-10 points.
Dizziness disability inventoryOther
The dizziness disability inventory was used to determine the disability level of the individuals participating in our study. It consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'.
Vertigo symptom scale-short formOther
The short form of the vertigo symptom scale was used to determine the frequency and duration of vertigo in the individuals participating in our study. The vertigo symptom scale consisting of 8 questions consists of vertigo (VSS-V), and the vertigo symptom scale consisting of 7 questions consists of two subsections consisting of a total of 15 questions: anxiety (VSS-A). Each item; Never (0), Very rarely (1 point), Often (2 points), Often - every week (3 points), Very often - On average, at least twice a week (4 points). The total score ranges from 0 to 60.
Hearing Impairment ScaleOther
The Adult Hearing Impairment Scale was used to determine the effect of the current hearing impairment levels of the individuals participating in our study on their daily living activities. The scale consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Participants mark the most appropriate expression for them.
Cervical Range of Motion (CROM 3) deviceOther
"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception and range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Temporomandibular joint range of motion assessmentOther
In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.
Posture evaluation with New York posture analysisOther
The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.
Evaluation of the anterior tilt angle of the headOther
Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.
Evaluation of postural balance with the Freemed pressure platformOther
Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.
Static balance assessment with tandem stance testOther
In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.
Dynamic balance assessment with tandem gait testOther
In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.
Headache, Temporomandibular pain and Craniocervical pain presence and severity assessmentOther
Headache, temporomandibular pain and craniocervical pain were asked to mark the person from the photographs taken from the front, back and side in the form of a human figure. Pain severity was evaluated with the numerical rating scale (NRS).
Pain sensitivity assessment in the head, neck, shoulder girdle and upper back regionOther
In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.
International physical activity questionnaire-measurement of physical activity level with shortOther
The short form of the international physical activity questionnaire was used to determine the physical activity level of the individuals participating in our study. The short form of the international physical activity questionnaire evaluates the last week and consists of a total of 4 sections and 7 questions. Duration of physical activity that requires intense physical effort, such as heavy lifting, soccer, or fast cycling; times of doing moderate physical activities that cause breathing slightly more often than usual; The total duration of walks at work, home, for sports, exercise and hobby, and the total sitting time spent in a day at work, at home or while resting are calculated.
Evaluation of sleep quality with the Pittsburgh sleep quality indexOther
The Pittsburgh Sleep Quality Index (PUKI) was used to evaluate the sleep quality and disturbance of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant responds to each item according to the frequency between 0-3 points. The total score (0-21 points) from these components indicates whether the sleep quality is good or not.
Evaluation of fatigue with the fatigue severity scaleOther
The Fatigue severity scale was used to evaluate the fatigue status of the individuals participating in our study. The scale uses a scoring system ranging from 1-7, which starts as I do not agree (1 point) and increases gradually towards I agree (7 point). It consists of 9 items in total and people mark the option that suits them.
Evaluation of anxiety-depression status with hospital anxiety and depression scaleOther
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the anxiety and depression status of the individuals participating in our study. For each item, the participant answers with a four-point (0-3 points) response option. Therefore, the possible score probabilities in line with the answers given are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, while the cut-off point for the depression subscale is 7 points.
Evaluation of quality of life with short form-12 (SF-12)Other
The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.
the International Fall Efficiency ScaleOther
The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 (no worries) to 64 (extremely worried).
assessment of muscle performanceOther
In our study, the strength of cervical flexors, anterior and oblique trunk flexors, cervical extensor muscles, back extensor muscles, trapezius muscle, and rhomboid major-minor muscles were evaluated. In addition, the endurance of the deep cervical flexor muscles, cervical flexors and cervical extensor muscles were also evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Meniere's disease | Voluntary Meniere's patients aged 18-65 years, not in the relapse period, who met the inclusion criteria Receives: Other: Case report form; Other: Tinnitus disability scale; Other: A feeling of fullness and/or pressure in the ear; Other: Dizziness intensity and frequency; Other: Dizziness disability inventory; Other: Vertigo symptom scale-short form; Other: Hearing Impairment Scale; Other: Cervical Range of Motion (CROM 3) device; Other: Temporomandibular joint range of motion assessment; Other: Posture evaluation with New York posture analysis; Other: Evaluation of the anterior tilt angle of the head; Other: Evaluation of postural balance with the Freemed pressure platform; Other: Static balance assessment with tandem stance test; Other: Dynamic balance assessment with tandem gait test; Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment; Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region; Other: International physical activity questionnaire-measurement of physical activity level with short; Other: Evaluation of sleep quality with the Pittsburgh sleep quality index; Other: Evaluation of fatigue with the fatigue severity scale; Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale; Other: Evaluation of quality of life with short form-12 (SF-12); Other: the International Fall Efficiency Scale; Other: assessment of muscle performance | |
| Healthy individuals without Meniere's disease | Volunteer healthy individuals aged 18-65 years without dizziness who met the inclusion criteria Receives: Other: Case report form; Other: Tinnitus disability scale; Other: A feeling of fullness and/or pressure in the ear; Other: Dizziness intensity and frequency; Other: Dizziness disability inventory; Other: Vertigo symptom scale-short form; Other: Hearing Impairment Scale; Other: Cervical Range of Motion (CROM 3) device; Other: Temporomandibular joint range of motion assessment; Other: Posture evaluation with New York posture analysis; Other: Evaluation of the anterior tilt angle of the head; Other: Evaluation of postural balance with the Freemed pressure platform; Other: Static balance assessment with tandem stance test; Other: Dynamic balance assessment with tandem gait test; Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment; Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region; Other: International physical activity questionnaire-measurement of physical activity level with short; Other: Evaluation of sleep quality with the Pittsburgh sleep quality index; Other: Evaluation of fatigue with the fatigue severity scale; Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale; Other: Evaluation of quality of life with short form-12 (SF-12); Other: the International Fall Efficiency Scale; Other: assessment of muscle performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the sense of proprioception with the "Cervical Range of Motion" (CROM) device
"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Measured: March 2023- May 2023
Evaluation of the range of motion (ROM) in the cervical region muscles with the "Cervical Range of Motion" (CROM) device
"Cervical Range of Motion" (CROM) device was used to evaluate the range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Measured: March 2023-May 2023
Temporomandibular joint range of motion assessment
In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.
Measured: March 2023- May 2023
Posture evaluation with New York posture analysis
The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.
Measured: March 2023- May 2023
Evaluation of the anterior tilt angle of the head
Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.
Measured: March 2023- May 2023
Evaluation of postural balance with the Freemed pressure platform
Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.
Measured: March 2023- May 2023
Static balance assessment with tandem stance test
In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.
Measured: March 2023- May 2023
Dynamic balance assessment with tandem gait test
In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.
Measured: March 2023- May 2023
Headache presence and severity assessment
The participant was asked to mark the places where the headache occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Measured: March 2023- May 2023
Craniocervical pain presence and severity assessment
The participant was asked to mark the areas of craniocervical pain from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Measured: March 2023-May 2023
Temporomandibular pain presence and severity assessment
The participant was asked to mark the places where temporomandibular pain occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Measured: March 2023-May 2023
Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.
Measured: March 2023- May 2023
Evaluation of sleep quality with the Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality and discomfort of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant answers each item between 0-3 points according to the frequency. The total score (0-21 points) from these components indicates whether the sleep quality is good or not. As the total score increases, sleep quality decreases and sleep disorder status increases. A total score of 5 or more indicates poor sleep quality.
Measured: March 2023- May 2023
Evaluation of fatigue with the fatigue severity scale
The Fatigue Severity Scale was used to evaluate the fatigue status of the individuals participating in our study. The Fatigue Severity Scale uses a scoring system ranging from 1-7, starting with disagree (1 point) and gradually increasing to agree (7 points). It consists of 9 items in total and people mark the option that suits them. Possibilities of total points that can be taken vary between 9-63 points. A score of 36 and above indicates that the level of fatigue is severe. The higher the score, the higher the level of fatigue.
Measured: March 2023- May 2023
Evaluation of anxiety-depression status with hospital anxiety and depression scale
The Hospital Anxiety and Depression Scale was used to evaluate the anxiety and depression status of the individuals participating in our study. The participant answers with a four-point (0-3 point) response option for each item. Therefore, according to the answers given, the possible score probabilities are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, and the cut-off point for the depression subscale is 7 points. The higher the total score, the higher the level of depression and anxiety.
Measured: March 2023- May 2023
Evaluation of quality of life with short form-12 (SF-12)
The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.
Measured: March 2023- May 2023
the International Fall Efficiency Scale
The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 to 64.
Measured: March 2023- May 2023
Secondary outcomes (9)
Tinnitus disability scale
Tinnitus disability scale was used to evaluate the tinnitus severity of Meniere's patients. It consists of 25 items in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Tinnitus level or severity is determined by calculating the total score of the answers given.
Measured: March 2023- May 2023
A feeling of fullness and/or pressure in the ear
The feeling of fullness or pressure in the ear was evaluated verbally by receiving yes/no responses from the participants.
Measured: March 2023- May 2023
Dizziness intensity and frequency
In order to determine the frequency and severity of dizziness, the participants were asked to mark the appropriate score between 1-10 points. 1 point indicates no dizziness, 10 points indicates continuous and extremely severe dizziness. As the score increases, the frequency and severity of dizziness also increase.
Measured: March 2023- May 2023
Dizziness disability inventory
The dizziness disability inventory was used to determine the disability level of the individuals participating in our study. It consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'.
Measured: March 2023- May 2023
Vertigo symptom scale-short form
The short form of the vertigo symptom scale was used to determine the frequency and duration of vertigo in the individuals participating in our study. The vertigo symptom scale consisting of 8 questions consists of vertigo (VSS-V), and the vertigo symptom scale consisting of 7 questions consists of two subsections consisting of a total of 15 questions: anxiety (VSS-A). Each item; Never (0), Very rarely (1 point), Often (2 points), Often - every week (3 points), Very often - On average, at least twice a week (4 points). The total score ranges from 0 to 60.
Measured: March 2023- May 2023
Hearing Impairment Scale
The Adult Hearing Impairment Scale was used to determine the effect of the current hearing impairment levels of the individuals participating in our study on their daily living activities. The scale consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Participants mark the most appropriate expression for them.
Measured: March 2023- May 2023
International physical activity questionnaire-measurement of physical activity level with short
The short form of the international physical activity questionnaire was used to determine the physical activity levels of the individuals participating in our study. The short form of the international physical activity questionnaire evaluates the last week and consists of a total of 4 sections and 7 questions. The duration of physical activity that requires intense physical exertion, such as heavy lifting, soccer, or fast cycling; times of doing moderate physical activities that cause breathing slightly more often than usual; The total duration of walks at work, home, sports, exercise and hobby, and the total sitting time spent in a day at work, at home or while resting are calculated. The physical activity score is calculated by converting the Metabolic Equivalent of Task, which corresponds to the basal metabolic rate. Total Metabolic Equivalent of Task value varies between 0-3000. The higher the total score, the higher the level of physical activity.
Measured: March 2023- May 2023
Assessment of muscle strength
In our study, the strength of cervical flexors, anterior and oblique trunk flexors, cervical extensor muscles, back extensor muscles, trapezius muscle and rhomboid major-minor muscles were evaluated.
Measured: March 2023- May 2023
Evaluation of muscle endurance
In our study, the endurance of deep cervical flexor muscles, neck cervical flexors and neck cervical extensor muscles were evaluated.
Measured: March 2023- May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 May 2023
- Primary completion4 Sep 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniere DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülistan Örenç, Hacettepe University
- Investigators
- Nezire Kose, Study director, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844657
- Sponsor's protocol ID
- Hacettepe Universitey
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjorne A, Agerberg G. Craniomandibular disorders in patients with Meniere's disease: a controlled study. J Orofac Pain. 1996 Winter;10(1):28-37.
PubMed 8995914Bjorne A, Agerberg G. Symptom relief after treatment of temporomandibular and cervical spine disorders in patients with Meniere's disease: a three-year follow-up. Cranio. 2003 Jan;21(1):50-60. doi: 10.1080/08869634.2003.11746232.
PubMed 12555932Yardley L, Dibb B, Osborne G. Factors associated with quality of life in Meniere's disease. Clin Otolaryngol Allied Sci. 2003 Oct;28(5):436-41. doi: 10.1046/j.1365-2273.2003.00740.x.
PubMed 12969347
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Physical and Psychosocial Status and Quality of Life of People With Meniere's Disease
- ClinicalTrials.gov ID
- NCT05844657
- Acronym / sponsor ID
- Hacettepe Universitey
- Keywords
- Meniere's disease, postural balance, posture, vertigo, tinnitus, proprioception, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 6 May 2023 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Meniere's disease | – | Other: Case report form, Other: Tinnitus disability scale, Other: A feeling of fullness and/or pressure in the ear, Other: Dizziness intensity and frequency, Other: Dizziness disability inventory, Other: Vertigo symptom scale-short form, Other: Hearing Impairment Scale, Other: Cervical Range of Motion (CROM 3) device, Other: Temporomandibular joint range of motion assessment, Other: Posture evaluation with New York posture analysis, Other: Evaluation of the anterior tilt angle of the head, Other: Evaluation of postural balance with the Freemed pressure platform, Other: Static balance assessment with tandem stance test, Other: Dynamic balance assessment with tandem gait test, Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment, Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region, Other: International physical activity questionnaire-measurement of physical activity level with short, Other: Evaluation of sleep quality with the Pittsburgh sleep quality index, Other: Evaluation of fatigue with the fatigue severity scale, Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale, Other: Evaluation of quality of life with short form-12 (SF-12), Other: the International Fall Efficiency Scale, Other: assessment of muscle performanceVoluntary Meniere's patients aged 18-65 years, not in the relapse period, who met the inclusion criteria |
| Healthy individuals without Meniere's disease | – | Other: Case report form, Other: Tinnitus disability scale, Other: A feeling of fullness and/or pressure in the ear, Other: Dizziness intensity and frequency, Other: Dizziness disability inventory, Other: Vertigo symptom scale-short form, Other: Hearing Impairment Scale, Other: Cervical Range of Motion (CROM 3) device, Other: Temporomandibular joint range of motion assessment, Other: Posture evaluation with New York posture analysis, Other: Evaluation of the anterior tilt angle of the head, Other: Evaluation of postural balance with the Freemed pressure platform, Other: Static balance assessment with tandem stance test, Other: Dynamic balance assessment with tandem gait test, Other: Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment, Other: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region, Other: International physical activity questionnaire-measurement of physical activity level with short, Other: Evaluation of sleep quality with the Pittsburgh sleep quality index, Other: Evaluation of fatigue with the fatigue severity scale, Other: Evaluation of anxiety-depression status with hospital anxiety and depression scale, Other: Evaluation of quality of life with short form-12 (SF-12), Other: the International Fall Efficiency Scale, Other: assessment of muscle performanceVolunteer healthy individuals aged 18-65 years without dizziness who met the inclusion criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with Meniere's disease and people with without Meniere's disease
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 |
|---|---|---|
| Case report formSociodemographic information (age, gender, height, body mass index, marital status, occupation, education level, contact information), frequency of smoking and alcohol use, frequency of caffeine consumption, frequency of salt consumption, dominant side, background, family history, medical and audiological information were recorded. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Tinnitus disability scaleTinnitus disability scale was used to evaluate the tinnitus severity of Meniere's patients. It consists of 25 items in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Tinnitus level or severity is determined by calculating the total score of the answers given. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| A feeling of fullness and/or pressure in the earThe feeling of fullness or pressure in the ear was evaluated verbally by receiving yes/no responses from the participants. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Dizziness intensity and frequencyIn order to determine the frequency and severity of dizziness, the participants were asked to mark the appropriate score between 1-10 points. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Dizziness disability inventoryThe dizziness disability inventory was used to determine the disability level of the individuals participating in our study. It consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Vertigo symptom scale-short formThe short form of the vertigo symptom scale was used to determine the frequency and duration of vertigo in the individuals participating in our study. The vertigo symptom scale consisting of 8 questions consists of vertigo (VSS-V), and the vertigo symptom scale consisting of 7 questions consists of two subsections consisting of a total of 15 questions: anxiety (VSS-A). Each item; Never (0), Very rarely (1 point), Often (2 points), Often - every week (3 points), Very often - On average, at least twice a week (4 points). The total score ranges from 0 to 60. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Hearing Impairment ScaleThe Adult Hearing Impairment Scale was used to determine the effect of the current hearing impairment levels of the individuals participating in our study on their daily living activities. The scale consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Participants mark the most appropriate expression for them. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Cervical Range of Motion (CROM 3) device"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception and range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Temporomandibular joint range of motion assessmentIn our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Posture evaluation with New York posture analysisThe New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Evaluation of the anterior tilt angle of the headAnterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Evaluation of postural balance with the Freemed pressure platformPostural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Static balance assessment with tandem stance testIn our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Dynamic balance assessment with tandem gait testIn our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Headache, Temporomandibular pain and Craniocervical pain presence and severity assessmentHeadache, temporomandibular pain and craniocervical pain were asked to mark the person from the photographs taken from the front, back and side in the form of a human figure. Pain severity was evaluated with the numerical rating scale (NRS). | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Pain sensitivity assessment in the head, neck, shoulder girdle and upper back regionIn our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| International physical activity questionnaire-measurement of physical activity level with shortThe short form of the international physical activity questionnaire was used to determine the physical activity level of the individuals participating in our study. The short form of the international physical activity questionnaire evaluates the last week and consists of a total of 4 sections and 7 questions. Duration of physical activity that requires intense physical effort, such as heavy lifting, soccer, or fast cycling; times of doing moderate physical activities that cause breathing slightly more often than usual; The total duration of walks at work, home, for sports, exercise and hobby, and the total sitting time spent in a day at work, at home or while resting are calculated. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Evaluation of sleep quality with the Pittsburgh sleep quality indexThe Pittsburgh Sleep Quality Index (PUKI) was used to evaluate the sleep quality and disturbance of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant responds to each item according to the frequency between 0-3 points. The total score (0-21 points) from these components indicates whether the sleep quality is good or not. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Evaluation of fatigue with the fatigue severity scaleThe Fatigue severity scale was used to evaluate the fatigue status of the individuals participating in our study. The scale uses a scoring system ranging from 1-7, which starts as I do not agree (1 point) and increases gradually towards I agree (7 point). It consists of 9 items in total and people mark the option that suits them. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Evaluation of anxiety-depression status with hospital anxiety and depression scaleThe Hospital Anxiety and Depression Scale (HADS) was used to evaluate the anxiety and depression status of the individuals participating in our study. For each item, the participant answers with a four-point (0-3 points) response option. Therefore, the possible score probabilities in line with the answers given are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, while the cut-off point for the depression subscale is 7 points. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| Evaluation of quality of life with short form-12 (SF-12)The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| the International Fall Efficiency ScaleThe International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 (no worries) to 64 (extremely worried). | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
| assessment of muscle performanceIn our study, the strength of cervical flexors, anterior and oblique trunk flexors, cervical extensor muscles, back extensor muscles, trapezius muscle, and rhomboid major-minor muscles were evaluated. In addition, the endurance of the deep cervical flexor muscles, cervical flexors and cervical extensor muscles were also evaluated. | Other | Healthy individuals without Meniere's disease, Individuals with Meniere's disease |
Primary outcome
Evaluating the sense of proprioception with the "Cervical Range of Motion" (CROM) device
Time frame: March 2023- May 2023
"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Evaluation of the range of motion (ROM) in the cervical region muscles with the "Cervical Range of Motion" (CROM) device
Time frame: March 2023-May 2023
"Cervical Range of Motion" (CROM) device was used to evaluate the range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Temporomandibular joint range of motion assessment
Time frame: March 2023- May 2023
In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.
Posture evaluation with New York posture analysis
Time frame: March 2023- May 2023
The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.
Evaluation of the anterior tilt angle of the head
Time frame: March 2023- May 2023
Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.
Evaluation of postural balance with the Freemed pressure platform
Time frame: March 2023- May 2023
Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.
Static balance assessment with tandem stance test
Time frame: March 2023- May 2023
In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.
Dynamic balance assessment with tandem gait test
Time frame: March 2023- May 2023
In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.
Headache presence and severity assessment
Time frame: March 2023- May 2023
The participant was asked to mark the places where the headache occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Craniocervical pain presence and severity assessment
Time frame: March 2023-May 2023
The participant was asked to mark the areas of craniocervical pain from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Temporomandibular pain presence and severity assessment
Time frame: March 2023-May 2023
The participant was asked to mark the places where temporomandibular pain occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
Time frame: March 2023- May 2023
In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.
Evaluation of sleep quality with the Pittsburgh sleep quality index
Time frame: March 2023- May 2023
The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality and discomfort of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant answers each item between 0-3 points according to the frequency. The total score (0-21 points) from these components indicates whether the sleep quality is good or not. As the total score increases, sleep quality decreases and sleep disorder status increases. A total score of 5 or more indicates poor sleep quality.
Evaluation of fatigue with the fatigue severity scale
Time frame: March 2023- May 2023
The Fatigue Severity Scale was used to evaluate the fatigue status of the individuals participating in our study. The Fatigue Severity Scale uses a scoring system ranging from 1-7, starting with disagree (1 point) and gradually increasing to agree (7 points). It consists of 9 items in total and people mark the option that suits them. Possibilities of total points that can be taken vary between 9-63 points. A score of 36 and above indicates that the level of fatigue is severe. The higher the score, the higher the level of fatigue.
Evaluation of anxiety-depression status with hospital anxiety and depression scale
Time frame: March 2023- May 2023
The Hospital Anxiety and Depression Scale was used to evaluate the anxiety and depression status of the individuals participating in our study. The participant answers with a four-point (0-3 point) response option for each item. Therefore, according to the answers given, the possible score probabilities are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, and the cut-off point for the depression subscale is 7 points. The higher the total score, the higher the level of depression and anxiety.
Evaluation of quality of life with short form-12 (SF-12)
Time frame: March 2023- May 2023
The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.
the International Fall Efficiency Scale
Time frame: March 2023- May 2023
The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 to 64.
9 secondary outcomes
Tinnitus disability scale
Time frame: March 2023- May 2023
A feeling of fullness and/or pressure in the ear
Time frame: March 2023- May 2023
Dizziness intensity and frequency
Time frame: March 2023- May 2023
Dizziness disability inventory
Time frame: March 2023- May 2023
Vertigo symptom scale-short form
Time frame: March 2023- May 2023
Hearing Impairment Scale
Time frame: March 2023- May 2023
International physical activity questionnaire-measurement of physical activity level with short
Time frame: March 2023- May 2023
Assessment of muscle strength
Time frame: March 2023- May 2023
Evaluation of muscle endurance
Time frame: March 2023- May 2023
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 13 Oct 2023.
- Background: PubMed 8995914Bjorne A, Agerberg G. Craniomandibular disorders in patients with Meniere's disease: a controlled study. J Orofac Pain. 1996 Winter;10(1):28-37.
- Background: PubMed 12555932Bjorne A, Agerberg G. Symptom relief after treatment of temporomandibular and cervical spine disorders in patients with Meniere's disease: a three-year follow-up. Cranio. 2003 Jan;21(1):50-60. doi: 10.1080/08869634.2003.11746232.
- Background: PubMed 12969347Yardley L, Dibb B, Osborne G. Factors associated with quality of life in Meniere's disease. Clin Otolaryngol Allied Sci. 2003 Oct;28(5):436-41. doi: 10.1046/j.1365-2273.2003.00740.x.
- Craniomandibular disorders in patients with Menière's disease: a controlled studyLink provided by the sponsor.
- Symptom relief after treatment of temporomandibular and cervical spine disorders in patients with Meniere's disease: a three-year follow-upLink provided by the sponsor.
- Factors associated with quality of life in Menière's diseaseLink provided by the sponsor.
- 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.
Nezire Kose study director
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniere Disease and Psychosocial Problem, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Oct 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 Turkey (Türkiye). 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?
Evaluating the sense of proprioception with the "Cervical Range of Motion" (CROM) device (time frame: March 2023- May 2023). The study lists 17 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 NCT05844657, which also lists 3 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 13 Oct 2023.