NCT02135900

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 1, 2015

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

July 4, 2012

Results QC Date

March 26, 2015

Last Update Submit

May 15, 2015

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

HelioxObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (1)

Heliox

EXPERIMENTAL

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

Interventions

HelioxDRUG

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.

Also known as: Helium/Oxygen
Heliox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep center, Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

helioxHeliumOxygen

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGasesChalcogens

Results Point of Contact

Title
Michel Chalhoub, MD
Organization
Staten Island University Hospital
chalhoubmichel@gmail.com
7182269000

Study Officials

  • Michel Chalhoub, MD

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2012

First Posted

May 12, 2014

Study Start

December 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 1, 2015

Results First Posted

June 1, 2015

Record last verified: 2015-05

Locations

US(1)