Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGOxytocin
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.
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * Men or women 18 years old or older of any ethnic background * Subjects that have recently undergone a standard in the sleep-lab diagnostic polysonmography (per standard of care medical guidelines), or the at home diagnostic test for cohort B, and have been diagnosed with OSA will be recruited into a follow-up study to assess the beneficial effects of oxytocin treatment.
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: 1. Appropriate medical documentation of prior complete bilateral oophorectomy OR 2. Permanent cessation of previously occurring menses as a result of ovarian failure with . documentation of hormonal deficiency. Ovarian hormonal deficiency is documented by . serum follicle stimulating hormone (FSH) level elevated to within the post-menopausal . . range based on the laboratory reference range where the hormonal assay is performed. 3. Menopause is defined as occurring 12 months after your last menstrual period and marks the . end of menstrual cycles * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Hypopnea Events | 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. |
| Frequency of Apnea Events | 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. |
Countries
United States
Participant flow
Pre-assignment details
8 subjects completed the PSG with intranasal oxytocin administered. There were 8 subjects total.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Oxytocin | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 43 years | — |
| Body Mass Index (BMI) | 28.3 (kg)/(m^2) | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: Duration of the overnight sleep study (variable)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Frequency of Apnea Events | 17.3 Incidence of apnea events | Standard Deviation 5.7 |
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.
Time frame: Duration of single overnight sleep study (variable)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Frequency of Hypopnea Events | 8.5 Incidence of hypopnea events | Standard Deviation 2 |