Sleep Quality After Nasosinusal Surgery in AERD Patients

NCT ID: NCT03627481

Last Updated: 2019-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aspirin-exacerbated Respiratory Disease Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AERD patients

Patients managed with Endoscopic sinus surgery for treatment of AERD.

Group Type EXPERIMENTAL

Endoscopic sinus surgery

Intervention Type PROCEDURE

Endoscopic sinus surgery for nasal polyposis

Interventions

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Endoscopic sinus surgery

Endoscopic sinus surgery for nasal polyposis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previously diagnosed sleep disorder.
* Psychiatric disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Enfermedades Respiratorias

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marcos Alejandro Jimenez Chobillon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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C34-18

Identifier Type: -

Identifier Source: org_study_id

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