Sleep Quality After Nasosinusal Surgery in AERD Patients
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|ClinicalTrials.gov Identifier: NCT03627481|
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2018
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aspirin-exacerbated Respiratory Disease Sleep||Procedure: Endoscopic sinus surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Quality After Nasosinusal Surgery in AERD Patients|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: AERD patients
Patients managed with Endoscopic sinus surgery for treatment of AERD.
Procedure: Endoscopic sinus surgery
Endoscopic sinus surgery for nasal polyposis
- Subjective sleep quality assessed by the Pittsburgh sleep quality index. [ Time Frame: 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.
- Objective sleep quality assessed by actigraphy. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627481
|Instituto Nacional de Enfermedades Respiratorias|
|Mexico City, Ciudad DE Mexico, Mexico, 14080|