Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

What Was Tested

This registered phase 2 trial tested Oxytocin for sleep apnea (obstructive).

OSA is a very prevalent disease with high cardiovascular risk factors, yet this disease remains very poorly treated.

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

In this research study, the effect oxytocin has on changes in heart rate or other Polysomnography (PSG) measures in a group of patients that have recently been diagnosed with OSA will be examined.

OSA is typically diagnosed through a polysomnography, a comprehensive recording of the biophysiological changes that occur during sleep.

The PSG monitors many body functions including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation (EMG) and heart rhythm (ECG) during sleep, respiratory airflow, respiratory effort, pulse oximetry etc.

In this research study, subjects who have recently been diagnosed with OSA will undergo two research study PSGs.

Who Took Part

Enrollment: 32 actual participants took part.

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 old or older of any ethnic background. Subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines), or the "at home" diagnostic test, and have been diagnosed with OSA.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: pregnant or breastfeeding women; subjects who are on medications that affect cardiac autonomic function (eg. beta blockers); active smokers.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the sleep apnea (obstructive) participants took both Oxytocin and the comparison in turn, acting as their own control.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-07-27 with completion listed for 2020-06-07.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Duration of Obstructive Events (time frame: Assessed on Visit 1- Day 1, Visit 2- Day 29).

It also tracked 3 secondary outcomes, for example Respiratory Rate, Incidence Proportion of Bradycardia and O2 Minimum.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 32 people with sleep apnea (obstructive).

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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