Sleep Quality After Nasosinusal Surgery in AERD Patients

Sleep Clinical Trial

Official title:

Sleep Quality After Nasosinusal Surgery in AERD Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03627481
• Other study ID #: C34-18
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• AERD patients.

• Cumbersome nasal polyposis with poor treatment response

Exclusion Criteria:

• Previously diagnosed sleep disorder.

• Psychiatric disorder

Related Conditions & MeSH terms

• Aspirin-exacerbated Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases
• Sleep

Intervention

Procedure:
• Endoscopic sinus surgery
Endoscopic sinus surgery for nasal polyposis

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias	Mexico City	Ciudad DE Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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