Expired Study
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Washington, District of Columbia 20036


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02564068


Primary Contact:

Principal Investigator
Vivek Jain, MD
The George Washington University


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20036
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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