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In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease with high cardiovascular risk factors, yet this disease remains very poorly treated. This proposal, based on the current literature and new basic science results detailed above on the role of oxytocin in cardiovascular control, will test if oxytocin administration improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding to test this important hypotheses more thoroughly and in larger clinical trials.
This study will explore if intranasal oxytocin has any positive cardiovascular benefits in patients with sleep apnea.
Cohort A: 8 Subjects
8 Subjects that have recently undergone either a standard "in the sleep-lab" diagnostic polysomnography or an "at home" PSG test and have been diagnosed with OSA will be recruited into the research study where we will assess the beneficial effects of oxytocin treatment.
These 8 subjects will undergo an "in the sleep-lab" diagnostic polysomnography that would be identical to the one they had for standard of care medical guidelines if they were diagnosed with OSA "in the sleep-lab". This research polysomnography should be performed within 4 weeks of their OSA diagnosis PSG.
These 8 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | These 8 subjects will undergo an "in the sleep-lab" diagnostic polysomnography that would be identical to the one they had for standard of care medical guidelines if they were diagnosed with OSA "in the sleep-lab". |
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| Oxytocin | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Hypopnea Events | 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. | Duration of single overnight sleep study (variable) |
| Frequency of Apnea Events | 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. | Duration of the overnight sleep study (variable) |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Pregnant or nursing women or women at any child bearing age who are not willing to undergo . methods to prevent pregnancy
A female subject of childbearing potential is a nonmenopausal female who has not had a . hysterectomy, bilateral oopherectomy, or medically documented ovarian failure. Menopause . can be assumed to have occurred in a woman when there is either:
Subjects who are on medications that affect cardiac autonomic function (eg. Beta blockers)
Smokers
Subjects who are unable to read or answer questions in the English language
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Jain, MD | The George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GW-Medical Faculty Associates | Washington D.C. | District of Columbia | 20036 | United States |
IPD is not currently planned to be shared with other researchers
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8 subjects completed the PSG with intranasal oxytocin administered. There were 8 subjects total.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | 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. |
| 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 | Frequency of Hypopnea Events | 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. | Posted | Mean | Standard Deviation | Incidence of hypopnea events | Duration of single overnight sleep study (variable) |
|
1 year, 7 months
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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 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivek Jain | Medical Faculty Associates at The George Washington University | 202-741-2676 | vjain@mfa.gwu.edu |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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All members of the research team except the IP dispensing staff will be blinded for the duration of the research study. Once all the subjects have finished in the research study, and all data is data-locked, the outcomes assessor will then unblind the research data for the statistical analysis.
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Full Range | (kg)/(m^2) |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Frequency of Apnea Events | 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. | Posted | Mean | Standard Deviation | Incidence of apnea events | Duration of the overnight sleep study (variable) |
|
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|
| 0 |
| 8 |
| 0 |
| 8 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |