The Use of Heliox in Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome Clinical Trial

— HOSA  

Official title:

The Use of Heliox in Obstructive Sleep Apnea Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135900
• Other study ID #: 09-046
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2012
• Last updated: May 15, 2015
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Drug:
• Heliox
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.

Locations

Country	Name	City	State
United States	Sleep center, Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No