Polysomnographic Findings in Nasal Polyposis

NCT03725956 | Recruiting

• 2 other identifiers: 2018_192018-A01650-55
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Obstructive Sleep Apnea

Keywords

Nasal polyposis; sleep; sinus surgery; polysomnography; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

Study Arms (1)

endoscopic sinus surgery

EXPERIMENTAL

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

Procedure: Endoscopic sinus surgery

Interventions

Endoscopic sinus surgery 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

endoscopic sinus surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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…)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Nasal Polyps

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Geoffrey Mortuaire, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey Mortuaire, MD

CONTACT

03 20 44 56 72; geoffrey.mortuaire@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 31, 2018
• Study Start: January 17, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)