An interventional study of Endoscopic sinus surgery in Aspirin-exacerbated Respiratory Disease and Sleep, sponsored by Instituto Nacional de Enfermedades Respiratorias. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-07.
Sponsored by Instituto Nacional de Enfermedades Respiratorias · Not applicable, Interventional, and Treatment
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.
617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 381 interventional studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →Instituto Nacional de Enfermedades Respiratorias is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Basal; 1, 3 and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto Nacional de Enfermedades Respiratorias