Trial Outcomes & Findings for Oxytocin on HR in Sleep Apnea Patient (NCT NCT02564068)
NCT ID: NCT02564068
Last Updated: 2023-11-27
Results Overview
Hypopnea events are defined as a reduction in ventilation of 30% that lasted for at least 10 s and resulted in a decrease in arterial saturation of 4% or more. The frequency of hypopnea events is the number of times these events took place during the overnight sleep study.
COMPLETED
EARLY_PHASE1
8 participants
Duration of single overnight sleep study (variable)
2023-11-27
Participant Flow
8 subjects completed the PSG with intranasal oxytocin administered. There were 8 subjects total.
Participant milestones
| Measure |
Oxytocin Only
Subjects will come in for one visit, and will receive only oxytocin
Oxytocin: To test that intranasal oxytocin administration blunts the deleterious hypoxia/hypercapnia induced changes in heart rate that occur during nocturnal apnea in patients with OSA, we will examine the changes in heart rate in a group of patients that have recently been diagnosed with OSA. Ten subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines, and not for research purposes) and have been diagnosed with OSA will be recruited into a study to assess the beneficial effects of oxytocin treatment.
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|---|---|
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Overall Study
STARTED
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8
|
|
Overall Study
COMPLETED
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8
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oxytocin
n=8 Participants
These subjects will undergo another "in the sleep-lab" diagnostic polysomnography that is identical to the one that they had for standard of care to diagnose OSA. Within one hour prior to the research polysomnography the subjects will be given oxytocin (40 IU) intranasally. Outcome measures will be assessed.
Oxytocin: To test that intranasal oxytocin administration blunts the deleterious hypoxia/hypercapnia induced changes in heart rate that occur during nocturnal apnea in patients with OSA, we will examine the changes in heart rate in a group of patients that have recently been diagnosed with OSA. 8 subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines, and not for research purposes) and have been diagnosed with OSA will be recruited into a study to assess the beneficial effects of oxytocin treatment.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
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8 Participants
n=8 Participants
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Age, Categorical
>=65 years
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0 Participants
n=8 Participants
|
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Age, Continuous
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43 years
n=8 Participants
|
|
Sex: Female, Male
Female
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3 Participants
n=8 Participants
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Sex: Female, Male
Male
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5 Participants
n=8 Participants
|
|
Region of Enrollment
United States
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8 participants
n=8 Participants
|
|
Body Mass Index (BMI)
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28.3 (kg)/(m^2)
n=8 Participants
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PRIMARY outcome
Timeframe: Duration of single overnight sleep study (variable)Hypopnea events are defined as a reduction in ventilation of 30% that lasted for at least 10 s and resulted in a decrease in arterial saturation of 4% or more. The frequency of hypopnea events is the number of times these events took place during the overnight sleep study.
Outcome measures
| Measure |
Oxytocin
n=8 Participants
These subjects will undergo another "in the sleep-lab" diagnostic polysomnography that is identical to the one that they had for standard of care to diagnose OSA. Within one hour prior to the research polysomnography the subjects will be given oxytocin (40 IU) intranasally. Outcome measures will be assessed.
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|---|---|
|
Frequency of Hypopnea Events
|
8.5 Incidence of hypopnea events
Standard Deviation 2.0
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PRIMARY outcome
Timeframe: Duration of the overnight sleep study (variable)Apnea events are defined as instances of reduction in the peak signal excursion of 90% lasting at least 10 s. Frequency of apnea events is the incidence of these events during a single, over-night sleep study.
Outcome measures
| Measure |
Oxytocin
n=8 Participants
These subjects will undergo another "in the sleep-lab" diagnostic polysomnography that is identical to the one that they had for standard of care to diagnose OSA. Within one hour prior to the research polysomnography the subjects will be given oxytocin (40 IU) intranasally. Outcome measures will be assessed.
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|---|---|
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Frequency of Apnea Events
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17.3 Incidence of apnea events
Standard Deviation 5.7
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Adverse Events
Oxytocin Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vivek Jain
Medical Faculty Associates at The George Washington University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place