The Use of Heliox in Obstructive Sleep Apnea Syndrome

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

Detailed Description
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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.

Official Title
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The Use of Heliox in Obstructive Sleep Apnea Syndrome.

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Drug: Heliox


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heliox<br>Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study. | Drug: Heliox<br>* From 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.<br>* Other names: Helium/Oxygen;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heliox, Obstructive Sleep Apnea