Polysomnographic Findings in Nasal Polyposis (POLYSOMNO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Procedure: Endoscopic sinus surgery

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoffrey Mortuaire, MD; Phone Number: +33 03 20 44 56 72; Email: geoffrey.mortuaire@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Claude Huriez, CHU
    • Principal Investigator: Geoffrey Mortuaire, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endoscopic sinus surgery; Single group of patients with nasal polyposis eligible for endoscopic sinus surgery	Procedure: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Geoffrey Mortuaire, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: polysomnography; sleep; quality of life; Nasal polyposis; sinus surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Sleep Apnea Syndromes; Nose Diseases; Sleep Apnea, Obstructive; Nasal Polyps; Polyps
• Other Study ID Numbers: 2018_19; 2018-A01650-55 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No