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

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ClinicalTrials.gov Identifier: NCT02135900
Recruitment Status : Completed
First Posted : May 12, 2014
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Michel Chalhoub, Northwell Health

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Drug: Heliox Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Heliox in Obstructive Sleep Apnea Syndrome.
Study Start Date : December 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Heliox

Arm Intervention/treatment
Experimental: Heliox
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
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.
Other Name: Helium/Oxygen




Primary Outcome Measures :
  1. Apnea Hypopnea Index [ 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. ]
    Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.

  2. Apnea Index (AI) [ 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. ]
    Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.

  3. Lowest Oxygen Saturation (L SO2) [ Time Frame: Baseline and in 6-8 hours. ]
    Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.

  4. Mean Oxygen Saturation (M SO2) [ Time Frame: Baseline and in 6-8 hours. ]
    Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135900


Locations
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United States, New York
Sleep center, Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
Investigators
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Principal Investigator: Michel Chalhoub, MD Staten Island University Hospital
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Responsible Party: Michel Chalhoub, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT02135900    
Other Study ID Numbers: 09-046
First Posted: May 12, 2014    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by Michel Chalhoub, Northwell Health:
Heliox
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases