The Use of Heliox in Obstructive Sleep Apnea Syndrome

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Drug: Heliox

• Registration Number: NCT02135900
• Lead Sponsor: Northwell Health

Brief 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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-12
• Results First Submitted: 2015-03-26
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-15
• Last Update Submitted: 2015-05-15
• Results First Posted: 2015-06-01
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.

Exclusion Criteria

• Professional singers.
• Television or Radio hosts.
• Disk Jockeys.
• Subjects requiring oxygen therapy.
• Subjects younger than 18 year old.
• Pregnant women.
• Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
• History of anatomic upper airway obstruction.
• Uncontrolled asthma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heliox	Heliox	Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.

Primary Outcome Measures

Name	Time	Method
Lowest Oxygen Saturation (L SO2)	Baseline and in 6-8 hours.	Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Apnea Hypopnea Index	Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.	Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Apnea Index (AI)	Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.	Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Mean Oxygen Saturation (M SO2)	Baseline and in 6-8 hours.	Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.

Trial Locations

Locations (1)

Sleep center, Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States