A study for adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) – open recruitment

Sudden idiopathic deafness is characterized by rapidly progressive hearing loss, almost always affecting only one ear, which appears within 72 hours. Most cases are idiopathic, meaning there is no single specific cause. Symptoms usually appear in the morning and include fullness in the ear, a feeling of cotton residue in the ear, ear blockage, sometimes even tinnitus (ringing, buzzing) and vertigo.

If you suddenly, for unknown reasons, stopped hearing in one ear, report to us as soon as possible!

We are looking for individuals who have experienced sudden, idiopathic (of unknown origin), unilateral hearing loss and have not yet undergone treatment after the onset of symptoms. If you report to us within 2–5 days of the first symptoms appearing, you can take part in a clinical trial conducted by the best specialists at the Center for Hearing and Speech MEDINCUS in Kajetany.

All clinical trials at the Center for Hearing and Speech MEDINCUS are conducted under the supervision of an independent Bioethics Committee and with the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Study in adults with rhinosinusitis with nasal polyps – recruitment closed

Chronic rhinosinusitis is a medical term for inflammation (swelling) of the lining of the sinuses and nose that lasts a long time or keeps returning. Nasal polyps are benign growths inside the nose near the openings leading to the sinuses.

The VIBRANT study evaluates an investigational drug injection administered to adult participants with chronic rhinosinusitis with nasal polyps. During this study, you may also receive rescue medication to control symptoms of rhinosinusitis.

To qualify for this study, you must:

  • Be between 18 and 75 years old,
  • have been diagnosed with chronic rhinosinusitis with nasal polyps for at least 6 months.

This is not a complete list of eligibility criteria. The study physician will discuss the full inclusion criteria with you. For more information about the VIBRANT study, contact the research center.

Nasal polyps – recruitment closed

Chronic rhinosinusitis (CRS) is one of the most common diseases worldwide, affecting nearly 12% of the adult population. It is characterized by inflammation of the nose and sinus cavities. Approximately 20% of CRS patients have nasal polyps, which are non-cancerous tissue growths occurring within the nose or paranasal sinuses. Nasal polyps usually occur on both sides of the nasal cavity, however, their occurrence on one side is also possible.

Typical symptoms of nasal polyps include nasal blockage, nasal congestion, facial pressure or pain, and decreased or loss of smell, lasting longer than 12 weeks. They may also be accompanied by: nasal discharge, sneezing, postnasal drip, and mouth breathing.

  • We are looking for volunteers with a severe course of the disease, who have experienced a relapse of symptoms despite standard treatment, to participate in clinical trials to better understand the condition and help find new treatment methods.
  • Qualifying participants will receive travel cost reimbursement and free health check-ups.
  • Each participant will undergo a comprehensive package of qualifying tests, including CT diagnostics.
  • Each participant will receive free concomitant treatment in the form of intranasal corticosteroids.

All clinical trials at the Center for Hearing and Speech MEDINCUS are conducted under the supervision of an independent Bioethics Committee and with the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Meniere's Disease – recruitment closed

Meniere’s disease is considered to be associated with the expansion of endolymphatic spaces and the formation of so-called endolymphatic hydrops. The causes of hydrops are divided into mechanical and functional. Mechanical disturbances impede the flow of endolymph from its place of formation, i.e., the stria vascularis, to the place of absorption, i.e., the endolymphatic sac, which consequently leads to the formation of hydrops. This can lead to a sudden attack of vertigo caused by transient paralysis of the afferent neurons of the vestibulocochlear nerve. In turn, functional disturbances result from vascular spasm, which can lead to hypoxia. The activation of vasomotor disturbances can be a result of physical stimuli such as light, cold, stress, heat, overexertion, or hormonal disorders. In a certain group of patients, immunological disorders are considered the cause of the disease.

The diagnosis of Meniere’s disease is based on anamnesis, audiological examinations, and vestibular system examinations. Anamnesis includes information about sudden, recurrent attacks of vertigo, most often described as spinning of the surroundings, occurring together with tinnitus and unilateral progressive hearing loss. These symptoms may or may not be preceded by so-called pre-attack symptoms. Such symptoms include fullness in the ear with increasing tinnitus and hearing impairment. Attacks can last from several minutes to several hours. During an attack, the patient does not lose consciousness, and falls rarely occur. After an attack, the patient feels fatigued, and headaches may also appear. After an attack, patients may experience a feeling of unsteadiness when walking for several days.

Characteristic symptoms of the disease are: fluctuating hearing deterioration, episodic vertigo, tinnitus or ringing in the ears usually of a buzzing type. Symptoms are most severe and bothersome in the early stages; in later stages, when changes within the labyrinth are advanced, acute attacks are replaced by constant balance disorders with progressive hearing damage. Audiometric tests performed on patients usually confirm the presence of sensorineural hearing impairment. Hearing deterioration usually occurs after subsequent attacks.

Narożny W., Nyka W.M., Siebert J., Etiopatogeneza, diagnostyka i leczenie choroby Meniere’a, Wybrane problemy kliniczne, Via Medica 2007, pp. 152-158 Morawiec-Bajda A.Wodniak błędnika, [w:] Audiologia Kliniczna, Śliwińska-Kowalska M. (red.), Mediton, Łódź 2005, pp.85-88

SSNHL – Sudden Sensorineural Hearing Loss – recruitment closed

Sudden sensorineural hearing loss is defined as sensorineural hearing impairment of cochlear origin. It appears suddenly, without a recognized cause, most often unilaterally, and with varying degrees of severity. Hearing impairment may be accompanied by tinnitus and/or vertigo, as well as a feeling of blocked ear. The hearing loss lasts from 12 to 96 hours. The result of pure-tone audiometry indicates a loss on at least three adjacent frequencies.

In cases of sudden deafness, differential diagnosis is necessary, the basis of which is interdisciplinary cooperation. When the cause cannot be determined, we speak of the idiopathic form of SSNHL.

The main problem in the treatment of sudden deafness is that there is no proven therapeutic method that yields repeatable results.

Therefore, our center conducts research into new methods for treating this condition.

Based on: Marek Rogowski: „Nagła głuchota” [w:] Mariola Śliwińska-Kowalska (red.) „Audiologia Kliniczna”, pp.263-269 ,Łódź 2005

Vertigo – recruitment closed

Vertigo can be divided into central and peripheral. The causes of central disturbances may include vasculogenic disorders in the central nervous system, trauma, brain tumors, multiple sclerosis, epilepsy, and inflammation within the central nervous system. Peripheral vertigo, on the other hand, is an area of interest for otolaryngologists. The most common causes of this type of disorder are benign paroxysmal positional vertigo (BPPV), Meniere’s disease, inflammation within the vestibular neuron, and drug-induced vertigo – associated with the ototoxic effect of certain medications. For a proper diagnosis of the cause of vertigo, its character can be crucial, e.g., for BPPV vertigo, a short duration counted in seconds is characteristic, and attacks are triggered by so-called critical head positions. Nystagmus may also appear during attacks. In the case of Meniere’s disease, vertigo attacks usually last from several minutes to several hours. It is also characteristic that vertigo may be accompanied by tinnitus, a feeling of fullness in the ear, and hearing impairment. Inflammation of the vestibular neuron can manifest as very severe vertigo with accompanying vomiting and nystagmus, without disturbances of the auditory organ. The duration of symptoms is days or even weeks. The caloric test in patients with this type of condition is positive. Inner ear damage associated with taken medications (aminoglycosides, cytostatics, loop diuretics, non-steroidal anti-inflammatory drugs) is not very common, but it should be suspected if the intake of an ototoxic drug is accompanied by vertigo along with tinnitus and hearing impairment. Litwin T., Członkowska A., Zawroty głowy w praktyce neurologa – diagnostyka i leczenie. Via Medica, ISSN 1734 -525, pp.78-86

Tinnitus – recruitment closed

Patients most often describe the bothersome sounds accompanying them as a hum, but they can also be perceived as ringing, whistling, hissing, gurgling, pulsating, howling, chirping, rustling of crumpled paper, and many other sounds. They can be felt in one or both ears or inside the head. They can also be intermittent or continuous. The character of tinnitus can change, as can its intensity and pitch. Tinnitus is a consequence of disturbances in various sections of the auditory pathway, most often these disturbances concern the inner ear. In the diagnosis of tinnitus, a very important aspect is the patient’s anamnesis, which can provide information about the probable etiology of tinnitus, its character, onset, and course. The second stage in the diagnosis of tinnitus is an otolaryngological examination including: otoscopy with assessment of tympanic membrane mobility, examination of the nasopharynx and patency of the Eustachian tube, and assessment of the existence of any sites in the head and neck area that may generate so-called objective tinnitus. The patient should also undergo otoneurological, audiological, and imaging diagnostics. Audiological diagnostics should include tests such as: audiogram, otoacoustic emissions, speech audiometry, tympanometry, stapedial reflexes. It is also important to perform a tinnitus characterization for the patient. Therapeutic management for tinnitus is divided into causal and symptomatic. Methods of tinnitus treatment include pharmacotherapy, tinnitus masking, electrostimulation, laser therapy, hyperbaric oxygen chambers, biofeedback method, psychotherapy, tinnitus habituation, and surgical treatment. Attempts are also made to treat with less conventional methods such as acupuncture and hypnosis. Bartnik G.,Szumy uszne – fakty istotne klinicznie,Magazyn Otorynolaryngologiczny, 2003,II,3(7)pp. 57-72 Rogowski M., Szumy uszne i nadwrażliwość słuchowa, (red.)Audiologia Kliniczna, Mediton, Łódź 2005, pp. 345-351 345-351

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E-mail badania.kliniczne@csim.pl M.Sc. Iwona Tomaszewska-Hert +48 22 46 35 342

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