Polysomnographic Findings in Nasal Polyposis

Obstructive Sleep Apnea Clinical Trial

— POLYSOMNO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03725956
• Other study ID #: 2018_19
• Secondary ID: 2018-A01650-55
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Lille
• Contact: Geoffrey Mortuaire, MD
• Phone: 03 20 44 56 72
• Email: geoffrey.mortuaire[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Obstructive Sleep Apnea
• Polyps
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in total sleep duration		At 1 month before surgery and at 3 months postoperatively
Secondary	Change in the number of brief wakefulness		At 1 month before surgery and at 3 months postoperatively
Secondary	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
Secondary	Change in time with oxygen desaturation below 90%		At 1 month before surgery and at 3 months postoperatively
Secondary	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