Ignite Creation Date:
2024-05-06 @ 7:36 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02564068
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2015-09-28
Brief Title:
Oxytocin on HR in Sleep Apnea Patient
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None