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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01650-55 | Other Identifier | ID-RCB number, ANSM |
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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.
the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic sinus surgery | Experimental | Single group of patients with nasal polyposis eligible for endoscopic sinus surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in total sleep duration | duration in min of total sleep at each endpoint | At 1 month before surgery and at 3 months postoperatively |
| Change in the number of brief wakefulness | comparison of the number of wakefulness between visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Mortuaire, MD | Contact | 03 20 44 56 72 | +33 | geoffrey.mortuaire@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Mortuaire, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHU | Recruiting | Lille | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| 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% | desaturation before anf after surgery measured | 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |