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RECRUITINGPhase 1INTERVENTIONAL

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

Benefits of Oxytocin in OSA Patients Using CPAP

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Men or women 18 years of age or older. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Oxytocin

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

DRUG

Placebo

Intranasal spray to mimic Oxytocin intranasal spray

Locations (1)

Medical Faculty Associates
Washington D.C., District of Columbia, United States