Using oxytocin nasal spray to reduce CPAP pressure in sleep apnea patients
Benefits of Oxytocin in OSA Patients Using CPAP
This study is testing if a nasal spray with oxytocin can help people with sleep apnea use lower pressure on their CPAP machines while they sleep.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | George Washington University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT03860233 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oxytocin administered via nasal spray on patients with obstructive sleep apnea who are using Continuous Positive Airway Pressure (CPAP) devices. It is a randomized, double-blinded, cross-over study involving 40 participants who will alternate between oxytocin and a placebo over a 35-night period. Participants will spend three nights in a sleep lab to monitor their sleep architecture and CPAP usage, while also providing blood samples for analysis of inflammatory markers. The goal is to determine if oxytocin can lower the pressure required from CPAP machines, potentially alleviating some harmful effects of low oxygen during sleep.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been using a CPAP device for at least one month.
Not a fit: Patients with other sleep disorders, those unable to use CPAP, or individuals who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective treatment for obstructive sleep apnea, reducing the pressure needed from CPAP machines and improving patient comfort.
How similar studies have performed: While the use of oxytocin in this context is novel, other studies have explored the effects of various treatments on CPAP efficacy, but this specific approach remains largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia
- Medical Faculty Associates — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Vivek Jain, MD — George Washington University
- Study coordinator: Vivek Jain, MD
- Email: vjain@mfa.gwu.edu
- Phone: 202-741-2237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.