RecruitingPhase 1NCT03860233

Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine

Benefits of Oxytocin in OSA Patients Using CPAP


Sponsor

Vivek Jain

Enrollment

40 participants

Start Date

Mar 4, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • Men or women 18 years of age or older.

Exclusion Criteria7

  • 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.

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Interventions

DRUGOxytocin

40 IU administered intranasal, within 1 hour prior to sleeping for 14 days

DRUGPlacebo

Intranasal spray to mimic Oxytocin intranasal spray


Locations(1)

Medical Faculty Associates

Washington D.C., District of Columbia, United States

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NCT03860233


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