Sleep Quality After Nasosinusal Surgery in AERD Patients

NCT03627481 | Unknown

• 1 other identifier: C34-18
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspirin-exacerbated Respiratory Disease; Sleep

Keywords

endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective sleep quality assessed by actigraphy.

  Basal; 3 and 6 months

• Quality of life assessed by the Asthma Quality of Life Questionnaire

  Basal; 1, 3 and 6 months

• Nasal symptoms assessed by the SNOT - 22

  Basal; 1, 3 and 6 months

• Asthma symptoms assessed by the Asthma Control Test.

  Basal; 1, 3 and 6 months

Study Arms (1)

AERD patients

EXPERIMENTAL

Patients managed with Endoscopic sinus surgery for treatment of AERD.

Procedure: Endoscopic sinus surgery

Interventions

Endoscopic sinus surgery PROCEDURE

Endoscopic sinus surgery for nasal polyposis

AERD patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previously diagnosed sleep disorder.
• Psychiatric disorder

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, 14080, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 13, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

ME (1)