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Hormone Therapy

Oxytocin for Sleep Apnea

Phase 1
Recruiting
Led By David Mendelowitz, PhD
Research Sponsored by Vivek Jain
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 5 weeks
Awards & highlights

Study Summary

This trial will see if oxytocin decreases the pressure needed from a CPAP device to sleep, which may help reduce some harmful effects from low oxygen in sleep apnea.

Who is the study for?
This trial is for men and women over 18 with obstructive sleep apnea who use a CPAP machine. It's not for those unwilling to use CPAP, with other sleep disorders, pregnant or breastfeeding women, or if they can't consent due to language barriers.Check my eligibility
What is being tested?
The study tests whether oxytocin nasal spray can reduce the pressure needed from a CPAP machine in sleep apnea patients. Participants will spend three nights in a lab at George Washington University over 35 days.See study design
What are the potential side effects?
While specific side effects are not listed here, oxytocin may cause potential side effects such as nasal irritation from the spray or systemic effects like altered heart rate or blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Use of oxytocin will change pressure required to keep open airway during auto-CPAP use
Secondary outcome measures
Change in total score for sleep quality with Post Polysomnogram Sleep Assessment
Change in total score of self-reported daytime sleepiness using Epworth Sleepiness Scale
Change in total score of self-reported sleep quality on Pittsburgh Quality Index

Trial Design

2Treatment groups
Experimental Treatment
Group I: Visit 2 Crossover RandomizationExperimental Treatment2 Interventions
At visit 2 subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal spray (40 IU) or Placebo Intranasal spray. Subjects will be blinded as to which drug they are receiving.
Group II: Visit 1 RandomizationExperimental Treatment2 Interventions
At visit 1subjects will receive one of two interventions: either Oxytocin Intranasal spray (40 IU) or Placebo Intranasal spray. Subjects will be blinded as to which drug they are receiving.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Vivek JainLead Sponsor
George Washington UniversityOTHER
243 Previous Clinical Trials
453,734 Total Patients Enrolled
1 Trials studying Sleep Apnea
8 Patients Enrolled for Sleep Apnea
David Mendelowitz, PhDPrincipal InvestigatorGeorge Washington University

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03860233 — Phase 1
Sleep Apnea Research Study Groups: Visit 1 Randomization, Visit 2 Crossover Randomization
Sleep Apnea Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT03860233 — Phase 1
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03860233 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants in this clinical trial?

"Affirmative, the information available on clinicaltrials.gov confirms that this medical trial is accepting participants and continues to do so since it was initially published in March of 2019 until its last alteration made in February 2022. 40 volunteers are required at a single location."

Answered by AI

What medicinal purposes is Oxytocin commonly employed for?

"Oxytocin is generally employed to control hemorrhage, but has also been found useful in aiding labour processes and uterine contractions."

Answered by AI

Are there any opportunities currently available to enroll in this trial?

"Affirmative, the clinicaltrials.gov website reveals that this medical investigation is actively recruiting participants. It was first introduced on March 4th 2019 and most recently updated on February 8th 2022. The study requires 40 individuals to be recruited from one medical centre."

Answered by AI

Has the FDA sanctioned Oxytocin for use?

"Given that this is a Phase 1 experiment, Oxytocin's safety score was set to 1 as there are only limited studies indicating the drug's efficacy and security."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
Medical Faculty Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Medical Faculty Associates: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine
Vivek Jain 2019. "Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03860233.
All > Apnea > Oxytocin
~3 spots leftby Oct 2024
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