Sleep Quality After Nasosinusal Surgery in AERD Patients
Primary Purpose
Aspirin-exacerbated Respiratory Disease, Sleep
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Endoscopic sinus surgery
Sponsored by
About this trial
This is an interventional treatment trial for Aspirin-exacerbated Respiratory Disease focused on measuring endoscopic sinus surgery
Eligibility Criteria
Inclusion Criteria:
- AERD patients.
- Cumbersome nasal polyposis with poor treatment response
Exclusion Criteria:
- Previously diagnosed sleep disorder.
- Psychiatric disorder
Sites / Locations
- Instituto Nacional de Enfermedades Respiratorias
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AERD patients
Arm Description
Patients managed with Endoscopic sinus surgery for treatment of AERD.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03627481
First Posted
July 4, 2018
Last Updated
February 6, 2019
Sponsor
Instituto Nacional de Enfermedades Respiratorias
1. Study Identification
Unique Protocol Identification Number
NCT03627481
Brief Title
Sleep Quality After Nasosinusal Surgery in AERD Patients
Official Title
Sleep Quality After Nasosinusal Surgery in AERD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Enfermedades Respiratorias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin-exacerbated Respiratory Disease, Sleep
Keywords
endoscopic sinus surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AERD patients
Arm Type
Experimental
Arm Description
Patients managed with Endoscopic sinus surgery for treatment of AERD.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sinus surgery
Intervention Description
Endoscopic sinus surgery for nasal polyposis
Primary Outcome Measure Information:
Title
Subjective sleep quality assessed by the Pittsburgh sleep quality index.
Description
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
Secondary Outcome Measure Information:
Title
Objective sleep quality assessed by actigraphy.
Description
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
Title
Quality of life assessed by the Asthma Quality of Life Questionnaire
Description
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
Title
Nasal symptoms assessed by the SNOT - 22
Description
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
Title
Asthma symptoms assessed by the Asthma Control Test.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AERD patients.
Cumbersome nasal polyposis with poor treatment response
Exclusion Criteria:
Previously diagnosed sleep disorder.
Psychiatric disorder
Facility Information:
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
State/Province
Ciudad DE Mexico
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sleep Quality After Nasosinusal Surgery in AERD Patients
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