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Polysomnographic Findings in Nasal Polyposis (POLYSOMNO)

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyps, Obstructive Sleep Apnea

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Endoscopic sinus surgery

About this trial

This is an interventional diagnostic trial for Chronic Rhinosinusitis With Nasal Polyps focused on measuring Nasal polyposis, sleep, sinus surgery, polysomnography, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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…)

Sites / Locations

Hôpital Claude Huriez, CHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endoscopic sinus surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Slow-wave sleep duration

Slow-wave sleep duration is measured one month before surgery and 3 months after surgery

Secondary Outcome Measures

change in total sleep duration

Change in the number of brief wakefulness

change in Apnea-hypopnea index

This index measures the number of apnea and hypopnea during the total sleep duration.

Change in time with oxygen desaturation below 90%

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

Full Information

NCT ID

NCT03725956

First Posted

October 18, 2018

Last Updated

May 17, 2022

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT03725956

Brief Title

Polysomnographic Findings in Nasal Polyposis

Acronym

POLYSOMNO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Rhinosinusitis With Nasal Polyps, Obstructive Sleep Apnea

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

endoscopic sinus surgery

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Endoscopic sinus surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Slow-wave sleep duration

Description

Slow-wave sleep duration is measured one month before surgery and 3 months after surgery

Time Frame

1 month before surgery and 3 months postoperatively

Secondary Outcome Measure Information:

Title

change in total sleep duration

Time Frame