Aspirin-exacerbated Respiratory Disease, Sleep
Conditions
Keywords
endoscopic sinus surgery
Brief summary
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.
Interventions
PROCEDUREEndoscopic sinus surgery
Endoscopic sinus surgery for nasal polyposis
Sponsors
Instituto Nacional de Enfermedades Respiratorias
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* AERD patients. * Cumbersome nasal polyposis with poor treatment response
Exclusion criteria
* Previously diagnosed sleep disorder. * Psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective sleep quality assessed by the Pittsburgh sleep quality index. | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective sleep quality assessed by actigraphy. | Basal; 3 and 6 months | Sleep efficiency as measured by actigraphy (worn for one week), basal and after. Efficiency is calculated as the average of eficiency for each night. |
| Quality of life assessed by the Asthma Quality of Life Questionnaire | Basal; 1, 3 and 6 months | 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. |
| Nasal symptoms assessed by the SNOT - 22 | Basal; 1, 3 and 6 months | 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. |
| Asthma symptoms assessed by the Asthma Control Test. | Basal; 1, 3 and 6 months | 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. |
Countries
Mexico
Outcome results
None listed