Trial Outcomes & Findings for The Use of Heliox in Obstructive Sleep Apnea Syndrome (NCT NCT02135900)
NCT ID: NCT02135900
Last Updated: 2015-06-01
Results Overview
Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
COMPLETED
PHASE2
32 participants
Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
2015-06-01
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Heliox in Obstructive Sleep Apnea Syndrome
Baseline characteristics by cohort
| Measure |
Heliox
n=32 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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23 Participants
n=39 Participants
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Age, Categorical
>=65 years
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9 Participants
n=39 Participants
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Age, Continuous
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52 years
STANDARD_DEVIATION 7 • n=39 Participants
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Sex: Female, Male
Female
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9 Participants
n=39 Participants
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Sex: Female, Male
Male
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23 Participants
n=39 Participants
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Region of Enrollment
United States
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32 participants
n=39 Participants
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PRIMARY outcome
Timeframe: 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
Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Outcome measures
| Measure |
Heliox
n=30 Participants
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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|---|---|
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Apnea Hypopnea Index
At baseline ( without Heliox)
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42.71 Apneas or hypopneas per hour sleep
Interval 33.16 to 52.25
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Apnea Hypopnea Index
after 6-8 hours ( with Heliox)
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40.95 Apneas or hypopneas per hour sleep
Interval 32.68 to 49.23
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PRIMARY outcome
Timeframe: 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
Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Outcome measures
| Measure |
Heliox
n=30 Participants
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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|---|---|
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Apnea Index (AI)
At baseline ( without Heliox)
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16.46 Number of apneas per hour sleep
Interval 7.59 to 25.33
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Apnea Index (AI)
after 6-8 hours ( with Heliox)
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11.26 Number of apneas per hour sleep
Interval 4.98 to 17.53
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PRIMARY outcome
Timeframe: Baseline and in 6-8 hours.Population: Subjects with documented sleep apnea syndrome on nocturnal polysomnography
Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Outcome measures
| Measure |
Heliox
n=30 Participants
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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|---|---|
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Lowest Oxygen Saturation (L SO2)
At baseline ( without Heliox)
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84.22 Percentage of oxygen saturation
Interval 82.07 to 86.38
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Lowest Oxygen Saturation (L SO2)
after 6-8 hours ( with Heliox)
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90.47 Percentage of oxygen saturation
Interval 88.71 to 92.23
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PRIMARY outcome
Timeframe: Baseline and in 6-8 hours.Population: Subjects with documented sleep apnea syndrome on nocturnal polysomnography
Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
Outcome measures
| Measure |
Heliox
n=30 Participants
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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|---|---|
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Mean Oxygen Saturation (M SO2)
At baseline ( without Heliox)
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93.47 Percentage of oxygen saturation
Interval 92.5 to 94.43
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Mean Oxygen Saturation (M SO2)
after 6-8 hours ( with Heliox)
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96.29 Percentage of oxygen saturation
Interval 95.51 to 97.07
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Adverse Events
Heliox
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place