Benefits of Oxytocin in OSA Patients Using CPAP
Vivek Jain
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.
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 spray not used initially (with a one week washout period in between). Subjects will have been using (for a minimum of 1 month) an auto-adjusting/titrating positive airway pressure (auto-CPAP device) as this is the mainstay of treatment for OSA and considered standard-of-care. All auto-CPAP devices are capable of recording frequency and duration of patient use (thus helping with compliance monitoring…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOxytocin
40 IU administered intranasal, within 1 hour prior to sleeping for 14 days
- DrugPlacebo
Intranasal spray to mimic Oxytocin intranasal spray
Location
- Medical Faculty AssociatesWashington D.C., District of Columbia