Nasality Evolution in a Nasal Polyposis Context : Multiparametric Evaluation : Articulatory (Imaging), Aerodynamics, Acoustics and Perception

NCT05131958 | Unknown DMC

• 1 other identifier: 2021-A00220-41
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

"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"

Conditions

Nasal Polyposis

Keywords

Nasal polyposis

Outcome Measures

Primary Outcomes (5)

• Aerodynamic

  For the aerodynamic measure : with a fibermask, we will record the nasal and oral airflow in liter/second

  Change before surgery and 3 months after surgery

• Acoustic measure

  For the acoustic measure with a microphone, we will record data in Hertz.

  Change before surgery and 3 months after surgery

• Perception measure

  To complete questionnaires : VHI

  Change before surgery and 3 months after surgery

• Perception measure

  To complete questionnaires : SHI

  Change before sugery and 3 months after surgery

• Perception measure

  To complete questionnaires : The nasal-speech relationship

  Change before surgery and 3 months after surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffering from primitive nasal polyposis and who had a surgery for the first time.

You may qualify if:

• Between 18 and 75 years of age
• Primitive nasal polyposis and surgery for the first time
• Not opposing to the study
• Affiliated to a social security systeme

You may not qualify if:

• Already had a surgery from the nasal and sinuses cavities
• Dysphonia or a vocal fold pathology
• One-sided or secondary nasal polyposis
• People who aren't able to give his non-opposition
• Contraindication to the airways endoscopy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Sorbonne University: collaborator

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-François PAPON, PhD

  AP-HP, Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François PAPON, PhD

CONTACT

0145213681; jean-françois.papon@aphp.fr

Lise Crevier Buchman, PhD

CONTACT

lise.buchman1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: November 23, 2021
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-07

Locations

FR (1)