Status:
RECRUITING
Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine
Lead Sponsor:
Vivek Jain
Collaborating Sponsors:
George Washington University
Conditions:
Sleep Apnea
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 slee...
Detailed Description
This is a rigorous randomized, double-blinded, cross-over study. Patients will self-administer either oxytocin nasal spray (40IU/ml), or sterile water spray, for 2 weeks, followed by 2 weeks of the sp...
Eligibility Criteria
Inclusion
- Men or women 18 years of age or older.
Exclusion
- 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.
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03860233
Start Date
March 4 2019
End Date
March 1 2026
Last Update
March 21 2025
Active Locations (1)
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1
Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037