Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | July 27, 2016 |
| End Date: | October 2019 |
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.
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.
Obstructive Sleep Apnea (OSA) is a major, yet poorly understood cardiovascular health risk
that occurs in as many as 24% of males and 9% of females within the US population. OSA can
participate in both the initiation and progression of several cardiovascular diseases
including sudden death, hypertension, arrhythmias, myocardial ischemia and stroke.
Many of the adverse cardiovascular consequences of OSA are thought to be associated with a
diminished cardiac vagal activity, as parasympathetic cardiac vagal activity is typically
cardio-protective. Intranasal administration of oxytocin has been shown to significantly
increase parasympathetic and decrease sympathetic cardiac control. In this research study,
the effect oxytocin has on changes in heart rate or other Polysomnography (PSG) measures in a
group of patients that have recently been diagnosed with OSA will be examined.
OSA is typically diagnosed through a polysomnography, a comprehensive recording of the
biophysiological changes that occur during sleep. The PSG monitors many body functions
including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation
(EMG) and heart rhythm (ECG) during sleep, respiratory airflow, respiratory effort, pulse
oximetry etc.
In this research study, subjects who have recently been diagnosed with OSA will undergo two
research study PSGs. Before the first study PSG, subjects will be randomized to receive
either Oxytocin (40 IU) or placebo, in a blinded manner, prior to beginning the test. The PSG
will then continue as usual, and subject data pertaining to the PSG will be gathered.
Subjects will then return within 4 weeks for a second research PSG, where one hour before the
test they will receive the opposite intervention that they did not received during the first
research PSG study. Data measurements will be re-measured and compared between the two PSGs.
that occurs in as many as 24% of males and 9% of females within the US population. OSA can
participate in both the initiation and progression of several cardiovascular diseases
including sudden death, hypertension, arrhythmias, myocardial ischemia and stroke.
Many of the adverse cardiovascular consequences of OSA are thought to be associated with a
diminished cardiac vagal activity, as parasympathetic cardiac vagal activity is typically
cardio-protective. Intranasal administration of oxytocin has been shown to significantly
increase parasympathetic and decrease sympathetic cardiac control. In this research study,
the effect oxytocin has on changes in heart rate or other Polysomnography (PSG) measures in a
group of patients that have recently been diagnosed with OSA will be examined.
OSA is typically diagnosed through a polysomnography, a comprehensive recording of the
biophysiological changes that occur during sleep. The PSG monitors many body functions
including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation
(EMG) and heart rhythm (ECG) during sleep, respiratory airflow, respiratory effort, pulse
oximetry etc.
In this research study, subjects who have recently been diagnosed with OSA will undergo two
research study PSGs. Before the first study PSG, subjects will be randomized to receive
either Oxytocin (40 IU) or placebo, in a blinded manner, prior to beginning the test. The PSG
will then continue as usual, and subject data pertaining to the PSG will be gathered.
Subjects will then return within 4 weeks for a second research PSG, where one hour before the
test they will receive the opposite intervention that they did not received during the first
research PSG study. Data measurements will be re-measured and compared between the two PSGs.
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
polysomnography (per standard of care medical guidelines), or the "at home" diagnostic
test, and have been diagnosed with OSA
Exclusion Criteria:
- Pregnant or Breastfeeding women
- Women of Child Bearing Potential who are not willing to undergo methods to prevent
pregnancy
- Subjects who are on medications that affect cardiac autonomic function (eg. Beta
Blockers)
- Active smokers
- Subjects who are unable to read or answer questions in the English language
We found this trial at
1
site
Washington, District of Columbia 20037
Principal Investigator: Vivek Jain, MD
Phone: 202-741-2342
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