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Hormone Therapy
Oxytocin on HR in Sleep Apnea Patient
Phase < 1
Waitlist Available
Led By Vivek Jain, MD
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of single overnight sleep study (variable)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a nasal spray of oxytocin can help heart health in people with sleep apnea. The hormone might balance the nervous system's control over the heart, reducing risks during sleep apnea episodes. Oxytocin has shown benefits in animal models of obstructive sleep apnea and has been tested in humans for its potential to reduce obstructive events.
Eligible Conditions
- Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of the overnight sleep study (variable)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the overnight sleep study (variable)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of Apnea Events
Frequency of Hypopnea Events
Side effects data
From 2023 Phase 4 trial • 108 Patients • NCT040287656%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: OxytocinExperimental Treatment1 Intervention
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.
Group II: ControlExperimental Treatment1 Intervention
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".
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340
Find a Location
Who is running the clinical trial?
George Washington UniversityLead Sponsor
254 Previous Clinical Trials
466,587 Total Patients Enrolled
1 Trials studying Sleep Apnea
40 Patients Enrolled for Sleep Apnea
Vivek Jain, MDPrincipal InvestigatorThe George Washington University
3 Previous Clinical Trials
351 Total Patients Enrolled
1 Trials studying Sleep Apnea
40 Patients Enrolled for Sleep Apnea