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Hormone Therapy

Oxytocin for Sleep Apnea

Phase 1

Recruiting

Led By Vivek Jain, MD

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

Must not have

Subjects not willing to or otherwise unable to use CPAP for treatment of OSA

Women of child-bearing age (WOCBA) not willing or unable to use an accepted method to avoid pregnancy for the entire duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable or unwilling to use CPAP for sleep apnea.

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I am a woman able to have children and will not use birth control during the study.

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I have been diagnosed with a sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Use of oxytocin will change pressure required to keep open airway during auto-CPAP use

Secondary study objectives

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

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

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