Oxytocin on HR in Sleep Apnea Patient
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Insomnia Sleep Studies, Peripheral Vascular Disease, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | March 2015 |
| End Date: | December 2019 |
Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
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.
Cohort A: 10 Subjects
10 subjects that have recently undergone a standard "in the sleep-lab" diagnostic
polysomnography (PSG) and have been diagnosed with OSA will be recruited into the research
study to assess the beneficial effects of oxytocin treatment.
These 10 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.
Cohort B: 10 Subjects
Once enrollment in Cohort A is complete, then enrollment into Cohort B will begin.
10 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 10 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.
Subjects will be randomized by the Investigational Drug Services Pharmacy of the MFA to be
administered either Oxytocin (40 IU) or placebo within one hour prior to beginning the study
polysomnography. Subjects will then return within 4 weeks to have a second research study
polysomnography performed by the sleep-lab. Subjects will be administered the intervention
that they did not received during the first research PSG study within one hour prior to
beginning the second polysomnography. Either Oxytocin (40 IU) or placebo. For example: If at
study polysomnography 1 a subject is randomized to receive placebo 1 hour prior to the start
of the polysomnography, then at study polysomnography 2 the subject will be administered
oxytocin (40 IU) 1 hour prior to the start of the polysomnography. Outcome measures will be
assessed.
10 subjects that have recently undergone a standard "in the sleep-lab" diagnostic
polysomnography (PSG) and have been diagnosed with OSA will be recruited into the research
study to assess the beneficial effects of oxytocin treatment.
These 10 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.
Cohort B: 10 Subjects
Once enrollment in Cohort A is complete, then enrollment into Cohort B will begin.
10 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 10 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.
Subjects will be randomized by the Investigational Drug Services Pharmacy of the MFA to be
administered either Oxytocin (40 IU) or placebo within one hour prior to beginning the study
polysomnography. Subjects will then return within 4 weeks to have a second research study
polysomnography performed by the sleep-lab. Subjects will be administered the intervention
that they did not received during the first research PSG study within one hour prior to
beginning the second polysomnography. Either Oxytocin (40 IU) or placebo. For example: If at
study polysomnography 1 a subject is randomized to receive placebo 1 hour prior to the start
of the polysomnography, then at study polysomnography 2 the subject will be administered
oxytocin (40 IU) 1 hour prior to the start of the polysomnography. Outcome measures will be
assessed.
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
We found this trial at
1
site
Washington, District of Columbia 20037
Principal Investigator: Vivek Jain, MD
Phone: 202-741-2342
Click here to add this to my saved trials
