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| Name | Class |
|---|---|
| Staten Island University Hospital | OTHER |
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The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Chalhoub, MD | Staten Island University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep center, Staten Island University Hospital | Staten Island | New York | 10305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heliox | Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Heliox | Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnea Hypopnea Index | Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox. | Subjects with documented sleep apnea syndrome on nocturnal polysomnography | Posted | Mean | 95% Confidence Interval | Apneas or hypopneas per hour sleep | Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heliox | Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michel Chalhoub, MD | Staten Island University Hospital | 7182269000 | chalhoubmichel@gmail.com |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C038949 | heliox |
| D006371 | Helium |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D018011 |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Apnea Index (AI) | Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox. | Subjects with documented sleep apnea syndrome on nocturnal polysomnography | Posted | Mean | 95% Confidence Interval | Number of apneas per hour sleep | Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox. |
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|
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| Primary | Lowest Oxygen Saturation (L SO2) | Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox. | Subjects with documented sleep apnea syndrome on nocturnal polysomnography | Posted | Mean | 95% Confidence Interval | Percentage of oxygen saturation | Baseline and in 6-8 hours. |
|
|
|
| Primary | Mean Oxygen Saturation (M SO2) | Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox. | Subjects with documented sleep apnea syndrome on nocturnal polysomnography | Posted | Mean | 95% Confidence Interval | Percentage of oxygen saturation | Baseline and in 6-8 hours. |
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| 0 |
| 32 |
| 0 |
| 32 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Chalcogens |