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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

Study 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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Apnea Events
Frequency of Hypopnea Events

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
243 Previous Clinical Trials
453,766 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Oxytocin on HR in Sleep Apnea Patient
Vivek Jain 2015. "Oxytocin on HR in Sleep Apnea Patient". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02564068.
~1 spots leftby Apr 2025
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