Oxytocin on HR in Sleep Apnea Patient

What Was Tested

The trial (early phase 1) is built around 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): Control (experimental) and Oxytocin (experimental).

These 8 subjects will undergo an "in the sleep-lab" diagnostic polysomnography that would be identical to the one they had for standard of care medical guidelines if they were diagnosed with OSA "in the sleep-lab".

The registry classes the interventions as drug.

More on the Plan

These 8 subjects will undergo an "in the sleep-lab" diagnostic polysomnography that would be identical to the one they had for standard of care medical guidelines if they were diagnosed with OSA "in the sleep-lab".

This research polysomnography should be performed within 4 weeks of their OSA diagnosis PSG.

These 8 subjects will undergo another "in the sleep-lab" diagnostic polysomnography that is identical to the one that they had for standard of care to diagnose OSA.

Outcome measures will be assessed.

Who Took Part

8 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.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: appropriate medical documentation of prior complete bilateral oophorectomy or; menopause is defined as occurring 12 months after your last menstrual period and marks the . end of menstrual cycles; subjects who are on medications that affect cardiac autonomic function (eg. beta blockers).

How the Study Was Run

The set-up was randomized, single-group and triple-blind.

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

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2015-05-22 with completion listed for 2016-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Frequency of Hypopnea Events (time frame: Duration of single overnight sleep study (variable)). Frequency of Apnea Events (time frame: Duration of the overnight sleep study (variable)).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 8 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.