Sleep Quality After Nasosinusal Surgery in AERD Patients

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.

Study Overview

• Status: Unknown
• Conditions: Sleep; Aspirin-exacerbated Respiratory Disease
• Intervention / Treatment: Procedure: Endoscopic sinus surgery

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Ciudad DE Mexico
    • Mexico City, Ciudad DE Mexico, Mexico, 14080
      • Instituto Nacional de Enfermedades Respiratorias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previously diagnosed sleep disorder.
• Psychiatric disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Basal; 1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Enfermedades Respiratorias

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: endoscopic sinus surgery
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: C34-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No