CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
Lying Head Back Position +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02079792
NCT02079792Phase 4Completed

The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device: A Randomized, Single-blind, Parallel Trial Comparing the Lying-Head-Back Versus the Head-Down-to-Floor Positions

St. Paul's Hospital, Canada·interventional·Posted Mar 6, 2014·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Lying Head Back Position and Head Down and Forward Position for Sinusitis. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 6, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.3 years ago

Interventions

Lying Head Back Positionprocedure

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.

Head Down and Forward Positionprocedure

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.