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Sleep Quality After Nasosinusal Surgery in AERD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627481
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Marcos Alejandro Jimenez Chobillon, Instituto Nacional de Enfermedades Respiratorias

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.

Condition or disease Intervention/treatment Phase
Aspirin-exacerbated Respiratory Disease Sleep Procedure: Endoscopic sinus surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: AERD patients
Patients managed with Endoscopic sinus surgery for treatment of AERD.
Procedure: Endoscopic sinus surgery
Endoscopic sinus surgery for nasal polyposis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AERD patients.
  • Cumbersome nasal polyposis with poor treatment response

Exclusion Criteria:

  • Previously diagnosed sleep disorder.
  • Psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627481


Locations
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Mexico
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Ciudad DE Mexico, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
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Responsible Party: Marcos Alejandro Jimenez Chobillon, Professor, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT03627481    
Other Study ID Numbers: C34-18
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcos Alejandro Jimenez Chobillon, Instituto Nacional de Enfermedades Respiratorias:
endoscopic sinus surgery
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases