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

What Was Tested

This registered phase 1 trial tested Oxytocin for sleep apnea (obstructive).

There are no additional costs to participants and no compensation for being involved in the study.

It had two arms (groups): Visit 1 Randomization (experimental) and Visit 2 Crossover Randomization (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a rigorous randomized, double-blinded, cross-over study.

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) and also recording the pressure needed to keep the airway open.

The end of the 2 week (14 day) period will mark day 14.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men or women 18 years of age or older.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: subjects not willing to or otherwise unable to use cpap for treatment of osa; presence of other sleep disorders; pregnant or breastfeeding women.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

The sleep apnea (obstructive) participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the sleep apnea (obstructive) participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-03-04 with completion listed for 2026-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Use of oxytocin will change pressure required to keep open airway during auto-CPAP use (time frame: 5 weeks).

It also tracked 3 secondary outcomes, for example Change in total score of self-reported daytime sleepiness using Epworth Sleepiness Scale, Change in total score of self-reported sleep quality on Pittsburgh Quality Index and Change in total score for sleep quality with Post Polysomnogram Sleep Assessment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 40 people with sleep apnea (obstructive).

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Sleep apnea (obstructive) research.