Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Heliox, Obstructive Sleep Apnea
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.
Interventions
DRUGHeliox
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.
Sponsors
Staten Island University Hospital
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | 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. |
| Apnea Index (AI) | 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. |
| Lowest Oxygen Saturation (L SO2) | Baseline and in 6-8 hours. | Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox. |
| Mean Oxygen Saturation (M SO2) | Baseline and in 6-8 hours. | Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Heliox |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Apnea Hypopnea Index
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.
Population: Subjects with documented sleep apnea syndrome on nocturnal polysomnography
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Heliox | Apnea Hypopnea Index | At baseline ( without Heliox) | 42.71 Apneas or hypopneas per hour sleep |
| Heliox | Apnea Hypopnea Index | after 6-8 hours ( with Heliox) | 40.95 Apneas or hypopneas per hour sleep |
Primary
Apnea Index (AI)
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.
Population: Subjects with documented sleep apnea syndrome on nocturnal polysomnography
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Heliox | Apnea Index (AI) | At baseline ( without Heliox) | 16.46 Number of apneas per hour sleep |
| Heliox | Apnea Index (AI) | after 6-8 hours ( with Heliox) | 11.26 Number of apneas per hour sleep |
Primary
Lowest Oxygen Saturation (L SO2)
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.
Population: Subjects with documented sleep apnea syndrome on nocturnal polysomnography
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Heliox | Lowest Oxygen Saturation (L SO2) | At baseline ( without Heliox) | 84.22 Percentage of oxygen saturation |
| Heliox | Lowest Oxygen Saturation (L SO2) | after 6-8 hours ( with Heliox) | 90.47 Percentage of oxygen saturation |
Primary
Mean Oxygen Saturation (M SO2)
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.
Population: Subjects with documented sleep apnea syndrome on nocturnal polysomnography
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Heliox | Mean Oxygen Saturation (M SO2) | At baseline ( without Heliox) | 93.47 Percentage of oxygen saturation |
| Heliox | Mean Oxygen Saturation (M SO2) | after 6-8 hours ( with Heliox) | 96.29 Percentage of oxygen saturation |