Skip to main content
OpenTrials
Completed

NCT Number: NCT02135900

The Use of Heliox in Obstructive Sleep Apnea Syndrome

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sleep center, Staten Island University Hospital

Staten Island, New York, 10305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heliox

Drug

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 names: Helium/Oxygen

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Staten Island University Hospital

Registry information

Official study title

The Use of Heliox in Obstructive Sleep Apnea Syndrome.

Acronym: HOSA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 12, 2014
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.