Polysomnographic Findings in Nasal Polyposis

Study Overview
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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.

Official Title
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Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps

Conditions
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Obstructive Sleep Apnea, Chronic Rhinosinusitis With Nasal Polyps

Intervention / Treatment
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* Procedure: Endoscopic sinus surgery


Participation Criteria
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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…)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic sinus surgery<br>Single group of patients with nasal polyposis eligible for endoscopic sinus surgery | Procedure: Endoscopic sinus surgery<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Slow-wave sleep duration | Slow-wave sleep duration is measured one month before surgery and 3 months after surgery | 1 month before surgery and 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in total sleep duration |  | At 1 month before surgery and at 3 months postoperatively | 
| Change in the number of brief wakefulness |  | At 1 month before surgery and at 3 months postoperatively | 
| change in Apnea-hypopnea index | This index measures the number of apnea and hypopnea during the total sleep duration. | At 1 month before surgery and at 3 months postoperatively | 
| Change in time with oxygen desaturation below 90% |  | At 1 month before surgery and at 3 months postoperatively | 
| change in Epworth sleepiness scale scores | The Epworth sleepiness scale score is a questionnaire based of 8 questions assessing daytime sleepiness. Each question is graded from 0 to 3. A total score ranging from 0 to 24 is established: 1 to 6 points: Normal sleep 7 to 8 points: Average sleepiness 9 to 24 points: Abnormal (possibly pathologic) sleepiness | At 1 month before surgery and at 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal polyposis, sleep, sinus surgery, polysomnography, quality of life