Polysomnographic Findings in Nasal Polyposis

Not Applicable

Recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps; Obstructive Sleep Apnea
• Interventions: Procedure: Endoscopic sinus surgery

• Registration Number: NCT03725956
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2019-01-17
• Status Verified: 2023-12
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endoscopic sinus surgery	Endoscopic sinus surgery	Single group of patients with nasal polyposis eligible for endoscopic sinus surgery

Primary Outcome Measures

Name	Time	Method
Change in Slow-wave sleep duration	1 month before surgery and 3 months postoperatively	Slow-wave sleep duration is measured one month before surgery and 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Change in the number of brief wakefulness	At 1 month before surgery and at 3 months postoperatively
change in Apnea-hypopnea index	At 1 month before surgery and at 3 months postoperatively	This index measures the number of apnea and hypopnea during the total sleep duration.
change in 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	At 1 month before surgery and at 3 months postoperatively	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

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France