Clinical Trials Directory

Trials / Completed

CompletedNCT02135900

The Use of Heliox in Obstructive Sleep Apnea Syndrome

The Use of Heliox in Obstructive Sleep Apnea Syndrome.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Northwell Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).

Detailed description

Obstructive sleep apnea syndrome (OSAS) is a common condition affecting up to 2-4 % of the general population. The pathophysiologic consequences of OSA include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (HTN), stroke and possibly coronary artery events. In addition, patients with severe and untreated obstructive sleep apnea (OSA) have increased mortality compared to patients with treated severe OSA.The main stay of treatment of OSAS is the application of continuous positive airway pressure (CPAP) during sleep. The main problem with CPAP therapy is compliance. Heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. In this study, the investigators will evaluate the effectiveness of Heliox in the treatment of OSAS. Adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for CPAP titration will be evaluated.

Conditions

Interventions

TypeNameDescription
DRUGHelioxFrom the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines.

Timeline

Start date
2009-12-01
Primary completion
2011-04-01
Completion
2011-04-01
First posted
2014-05-12
Last updated
2015-06-01
Results posted
2015-06-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02135900. Inclusion in this directory is not an endorsement.