Actively Recruiting
Benefits of Oxytocin Nasal Spray in Obstructive Sleep Apnea Patients Using CPAP Machine
Led by Vivek Jain · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vivek Jain
Lead Sponsor
G
George Washington University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether an intra-nasal spray of the drug oxytocin can reduce the pressure needed by an automatic Continuous Positive Airway Pressure (CPAP) machine during sleep in people with obstructive sleep apnea (OSA). This research aims to lessen harmful effects caused by low oxygen levels in individuals using CPAP for their condition. The trial is a randomized, double-blinded, crossover study involving adults who have used auto-adjusting CPAP devices for at least one month. Participants will self-administer either oxytocin nasal spray or a placebo spray intranasally for two weeks, followed by a one-week washout period, then switch to the other spray for another two weeks. The oxytocin dose is 40 IU per night, given as 10 nasal sprays before sleep. Throughout the 35-day study, participants continue to use their auto-CPAP devices as usual while researchers monitor pressure needs and compliance. The study includes three overnight sleep lab visits for detailed assessments. During the study, participants will have blood samples taken to analyze inflammatory markers and oxidative stress, overnight sleep studies to evaluate sleep quality and architecture, and downloads of CPAP compliance and pressure data. Researchers will assess changes in pressure required to keep the airway open and measure daytime sleepiness and sleep quality using questionnaires. The study lasts 35 nights with no costs to participants and no compensation provided.
CONDITIONS
Brief Title
Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 years of age or older
You will not qualify if you...
- Subjects not willing or unable to use CPAP for treatment of obstructive sleep apnea
- Presence of other sleep disorders
- Pregnant or breastfeeding women
- Women of child-bearing age not willing or unable to use an accepted method to avoid pregnancy during the study
- Prisoners or involuntarily incarcerated subjects
- Subjects compulsorily detained for psychiatric or physical illness
- Patients unable to give consent due to language barrier or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants self-administer either oxytocin nasal spray or placebo nasal spray nightly for 2 weeks while continuing to use their auto-CPAP machine as standard care. After a 1-week washout period, participants switch to the opposite nasal spray for another 2 weeks.
3 overnight in-lab sleep study visits and blood collection visits at Day 1, Day 14, and Day 35
Trial Site Locations
Total: 1 location
1
Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
V
Vivek Jain, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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