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The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device

NCT02079792 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-04-14

No results posted yet for this study

Summary

Chronic Rhinosinusitis (CRS) is a common disorder of the nose characterized by stuffy nose, discoloured nasal discharge, sinus congestion or pressure and decreased sense of smell, present for over twelve weeks. Anti-inflammatory steroid medication is often used to treat sinus inflammation in CRS. These steroids are sometimes delivered using a spray device that creates a mist to deliver steroid medication deep into the nose. However, the distribution and efficacy of sprayed medication can be affected by the position of the patient's head. This study aims to determine which of two head positions is best for delivering steroid to the sinuses.

Conditions

  • Sinusitis

Interventions

PROCEDURE

Lying Head Back Position

Subjects randomized to the LHB position will be instructed to lay supine on the clinical table, with their head hanging over the edge of the bed as far as possible without discomfort.

PROCEDURE

Head Down and Forward Position

Subjects randomized to the HDF position will be instructed to kneel down, placing the top of their head on the ground and forehead close to the knees with the nostrils facing upwards.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Amin R Javer, MD, FRCSC, FARS · St. Paul's Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079792 on ClinicalTrials.gov