Dataset Information

A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis

ABSTRACT: The study will evaluate the effect of ACT-774312 on the nasal polyps and will assess the safety and tolerability of ACT-774312 in the patients with bilateral nasal polyposis

DISEASE(S): Bilateral Nasal Polyposis,Nasal Polyps,Colorectal Neoplasms,Nasopharyngeal Neoplasms

PROVIDER: 2285477 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:"Nasal polyposis is a chronic inflammation of the sinonasal mucosa which is characterized by the development of polyps in the sinonasal cavities. In the general population, its prevalence is 4% with a clear increase from the age of 50 years. When drug treatment is not effective, and the patient’s quality of life is impaired, surgery is proposed. It allows to widen the nasal cavities with aerodynamic and acoustics effects on speech. There are few studies, that have focused on the impact of NP and its treatment on speech. Yet there is a real demand from patients to obtain answers related to the impact of this surgery on their voice. Preoperatively and postoperatively, the resonance will be disturbed: polyps will impacted the quality of the nasal sounds. And after surgery, the new anatomical shape can create an excessive resonance in the nasal cavities. Indeed, there is a diversity of acoustic effects that differ according to the sinuses involved, the nature and type of surgery and the anatomical and physiological specificities of the patient. The impairment of acoustic properties after surgery is diverse and little known. The surgery improves the communication between sinuses and nasal cavities but the real impact on nasal resonance still unknown. The particularity of this pathology stands in the obstruction of the sinonasal cavity by polyps. On this study, it represents a model of nasality disturbance/impairment ? Indeed, all aspects of nasality will be altered : the articulation by the obstruction of the sino-nasal cavities, the aerodynamic by a disturbance of the circulation of the airflow within the nasal cavity, acoustics by an alteration of the resonance of this flow, and finally the perception of speech by others where the comprehension of speech is difficult. Thus, the investigators wish to observe this dysfunction in a multipara metric way in order to have an accurate approach. This population is therefore ideal. In preoperative, it will allow to measure by aerodynamic, articulatory, acoustic, and perceptive data taking this dysfunction, to give precise answers. Then, postoperatively, these measurements will be repeated to observe a return to the expected functioning of the nasal cavity. Indeed, the cavities being no longer congested, a greater flow of nasal air would be expected, which would have acoustic consequences on the resonance of nasal sounds. This could be accentuated because of the new anatomical configuration due to the surgery. Perceptually, the voice after surgery should no longer be considered as pathological. In addition to the linguistics aspect, this population has the particularity of having a strongly impacted quality of life. The investigators would therefore like to measure this impact on quality of life before and after surgery. For this study, the main objective is to measure the articulatory, aerodynamics, acoustics and perceptive impact of the nasal polyposis on speech before and after surgery. the secondaries objectives are to: * Compare the differences in aerodynamic, acoustic, articulatory and perceptual changes between the ""presence of polyps in the nasal and sinus cavities"" group and the ""presence of polyps in the sinus cavities"" group * Compare the modifications on the speech of the pathology before and after surgical treatment * Identify the elements related to the quality of life impacted by this pathology. * Identify the glottic compensation strategies induced by the pathology * Compare preoperative and postoperative nasal resonance and the relationship between nasal and sinus cavities using 3D models * Validate the adequacy of the nasality-speech questionnaire for patients with sinonasal polyposis"

Dataset Information

A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis

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