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Polysomnographic Findings in Nasal Polyposis

NCT ID: NCT03725956

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2023-12-31

Brief Summary

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Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.

Detailed Description

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Conditions

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Chronic Rhinosinusitis With Nasal Polyps Obstructive Sleep Apnea

Keywords

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Nasal polyposis sleep sinus surgery polysomnography quality of life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endoscopic sinus surgery

Single group of patients with nasal polyposis eligible for endoscopic sinus surgery

Group Type EXPERIMENTAL

Endoscopic sinus surgery

Intervention Type PROCEDURE

Surgical procedure under general anaesthesia:

Consists of the removal of bone boundaries between sinus cavities (ethmoidectomy) with nasal polyps resection in order to retrieve nasal patency and sinus drainage Polysomnographic assessment as routinely applied in clinical practice

Interventions

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Endoscopic sinus surgery

Surgical procedure under general anaesthesia:

Consists of the removal of bone boundaries between sinus cavities (ethmoidectomy) with nasal polyps resection in order to retrieve nasal patency and sinus drainage Polysomnographic assessment as routinely applied in clinical practice

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient
* Patient willing to comply with all procedures of the study and its duration
* Patient giving consent

Exclusion Criteria

* Patients with previous nasal surgery for nasal polyposis
* Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea
* Non-coverage by the social security scheme
* Patient unable to receive informed information
* Refusal to sign the consent
* Person deprived of the liberty
* Person benefiting from a system of legal protection (guardianship…)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geoffrey Mortuaire, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHU

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Geoffrey Mortuaire, MD

Role: CONTACT

Phone: 03 20 44 56 72

Email: [email protected]

Other Identifiers

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2018-A01650-55

Identifier Type: OTHER

Identifier Source: secondary_id

2018_19

Identifier Type: -

Identifier Source: org_study_id