Sleep Quality After Nasosinusal Surgery in AERD Patients

Study Overview
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Brief Summary
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Aspirin exacerbated respiratory disease presents as a triad composed by asthma, eosinophilic rinosinusitis and intolerance to aspirin and NSAIDS. In subjects with chronic rhinosinusitis sleep alterations have been found, with important improvement after surgery, but those alterations and improvements have not been studied in patients diagnosed with AERD who, due to their comorbidities, may present more severe pre surgical symptoms and a more important post-surgical improvement. The investigators aim to study patients with AERD sleep, quality of life and symptoms before surgery, and one, three and six months post-surgery.

Official Title
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Sleep Quality After Nasosinusal Surgery in AERD Patients

Conditions
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Sleep, Aspirin-exacerbated Respiratory Disease

Intervention / Treatment
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* Procedure: Endoscopic sinus surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AERD patients. Cumbersome nasal polyposis with poor treatment response Exclusion Criteria: Previously diagnosed sleep disorder. Psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AERD patients<br>Patients managed with Endoscopic sinus surgery for treatment of AERD. | Procedure: Endoscopic sinus surgery<br>* Endoscopic sinus surgery for nasal polyposis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality assessed by the Pittsburgh sleep quality index. | Total score in Pittsburgh sleep quality index, basal and after surgery. Total score in Pittsburgh sleep quality index, before and after surgery. The Pittsburgh sleep quality index has a global score in which a higher score indicates a worse sleep quality, with a global score higher than five differentiating those with good and bad sleep quality. In order to obtain the global score, individual questions are grouped in seven components, to which a 0 to 3 score is assigned and all components scores are added. The total range of the global score goes from 0 to 21. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep quality assessed by actigraphy. | Sleep efficiency as measured by actigraphy (worn for one week), basal and after. Efficiency is calculated as the average of eficiency for each night. | Basal; 3 and 6 months | 
| Quality of life assessed by the Asthma Quality of Life Questionnaire | Evaluated with the Asthma Quality of Life Questionnaire, basal and after surgery. The questionnaire has 32 questions with four areas or dominions (activity limitations, asthma symptoms, emotional state and ambient exposition), each question is scored from 1 to 7, with 1 being maximum affectation and 7 no affectation. Final score for each area is obtained by averaging the score for the corresponding questions. | Basal; 1, 3 and 6 months | 
| Nasal symptoms assessed by the SNOT - 22 | Change in nasal symptoms evaluated via the SNOT 22 questionnaire, basal and after surgery. The sino-nasal outcome test (SNOT-22). This questionnaire is composed by 22 questions that are answered from 0 to 5, with 0 defining no burden and 5 maximal burden, with a total score range from 0 to 110, with a higher score indicating worse symptoms. The total score is obtained by adding the individual question scores. | Basal; 1, 3 and 6 months | 
| Asthma symptoms assessed by the Asthma Control Test. | Changes on symptoms as evaluated by the score on Asthma Control Test, basal and after surgery. The asthma control test (ACT) has five questions that are answered with scores from 1 to 5, with a total score (obtained by adding the individual question score) from 5 to 25. A higher score indicates worse asthma control. A total score of 19 is considered a cut point for uncontrolled patients. | Basal; 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic sinus surgery