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The Use of Heliox in Obstructive Sleep Apnea Syndrome (HOSA)

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heliox
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Heliox, Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sleep center, Staten Island University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heliox

Arm Description

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

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index
Assessment of Apnea/Hypopnea Index (AHI) 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.
Lowest Oxygen Saturation (L SO2)
Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Mean Oxygen Saturation (M SO2)
Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2012
Last Updated
May 15, 2015
Sponsor
Northwell Health
Collaborators
Staten Island University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02135900
Brief Title
The Use of Heliox in Obstructive Sleep Apnea Syndrome
Acronym
HOSA
Official Title
The Use of Heliox in Obstructive Sleep Apnea Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Staten Island University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Heliox, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heliox
Arm Type
Experimental
Arm Description
Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Intervention Type
Drug
Intervention Name(s)
Heliox
Other Intervention Name(s)
Helium/Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Time Frame
Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Title
Apnea Index (AI)
Description
Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Time Frame
Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Title
Lowest Oxygen Saturation (L SO2)
Description
Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Time Frame
Baseline and in 6-8 hours.
Title
Mean Oxygen Saturation (M SO2)
Description
Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Time Frame
Baseline and in 6-8 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Chalhoub, MD
Organizational Affiliation
Staten Island University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep center, Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

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The Use of Heliox in Obstructive Sleep Apnea Syndrome

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