Chronic Rhinosinusitis With Nasal Polyps, Obstructive Sleep Apnea
Conditions
Keywords
Nasal polyposis, sleep, sinus surgery, polysomnography, quality of life
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
the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
Interventions
PROCEDUREEndoscopic 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
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| change in total sleep duration | At 1 month before surgery and at 3 months postoperatively | duration in min of total sleep at each endpoint |
| Change in the number of brief wakefulness | At 1 month before surgery and at 3 months postoperatively | comparison of the number of wakefulness between visits |
| 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 time with oxygen desaturation below 90% | At 1 month before surgery and at 3 months postoperatively | desaturation before anf after surgery measured |
| 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 |
Countries
France
Contacts
CONTACTGeoffrey Mortuaire, MD
PRINCIPAL_INVESTIGATORGeoffrey Mortuaire, MD
University Hospital, Lille
Outcome results
None listed