NCT03860233 Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine
| NCT ID | NCT03860233 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vivek Jain |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-03-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2019-03-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will investigate if an intra-nasal nose spray of the drug oxytocin can decrease the amount of pressure needed from the automatic Continuous Positive Airway Pressure (CPAP) device while sleeping decreasing some of the harmful effects of low oxygen in people with sleep apnea. This study will last 35 nights and involves spending three nights in the sleep lab at George Washington University. There are no additional costs to participants and no compensation for being involved in the study.
Eligibility Criteria
Inclusion Criteria: * Men or women 18 years of age or older. Exclusion Criteria: * subjects not willing to or otherwise unable to use CPAP for treatment of OSA. * Presence of other sleep disorders * Pregnant or breastfeeding women * 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 * Prisoners or subjects who are involuntarily incarcerated * Subjects who are compulsorily detain or treatment of either a psychiatric or physical (i.e. infectious disease) illness * Patients unable to give consent because of a language barrier, or other reason.
Contact & Investigator
Vivek Jain, MD
PRINCIPAL INVESTIGATOR
George Washington University
Frequently Asked Questions
Who can join the NCT03860233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03860233 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03860233 currently recruiting?
Yes, NCT03860233 is actively recruiting participants. Contact the research team at vjain@mfa.gwu.edu for enrollment information.
Where is the NCT03860233 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT03860233 clinical trial?
NCT03860233 is sponsored by Vivek Jain. The principal investigator is Vivek Jain, MD at George Washington University. The trial plans to enroll 40 participants.