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Hormone Therapy

Control for Sleep Apnea

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

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 weeks
Treatment ~ Varies
Follow Up ~duration of the overnight sleep study (variable)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the overnight sleep study (variable) for reporting.

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 • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

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
250 Previous Clinical Trials
458,532 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
~1 spots leftby Oct 2025