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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

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)

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

Blood transfusion

100%

80%

60%

40%

20%

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

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