Recruiting
Phase 1

Oxytocin with CPAP

Sponsor:

Vivek Jain

Code:

NCT03860233

Conditions

Sleep Apnea

Sleep Apnea, Obstructive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxytocin

Placebo

Study Details

Brief 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.

Conditions

Sleep Apnea

Sleep Apnea, Obstructive

Study ID

NCT03860233

Start date

Mar 4, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Visit 1 Randomization

At visit 1subjects will receive one of two interventions: either Oxytocin Intranasal spray (40 IU) or Placebo Intranasal spray. Subjects will be blinded as to which drug they are receiving.

experimental: Visit 2 Crossover Randomization

At visit 2 subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal spray (40 IU) or Placebo Intranasal spray. Subjects will be blinded as to which drug they are receiving.

Interventions

Oxytocin

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

Placebo

Intranasal spray to mimic Oxytocin intranasal spray

Primary outcome measure

  • Use of oxytocin will change pressure required to keep open airway during auto-CPAP use [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Vivek Jain, MD

202-741-2237vjain@mfa.gwu.edu

Locations

Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Vivek Jain, MD

202-741-2237vjain@mfa.gwu.edu

David Mendelowitz, PhD

202-994-3466

More Information

Sponsor

Vivek Jain

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Continuous Positive Airway Pressure
  • CPAP
  • Oxytocin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vivek Jain on 2026-05-04.