NCT02564068

Oxytocin on HR in Sleep Apnea Patient

Completed EARLY_PHASE1 Results posted Last updated 27 November 2023

What this trial tests

EARLY_PHASE1 trial testing Oxytocin in Sleep Apnea in 8 participants. Completed in 31 December 2016.

Timeline

22 May 2015

Primary endpoint
31 December 2016

31 December 2016

Quick facts

Lead sponsor	George Washington University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	8
Start date	22 May 2015
Primary completion	31 December 2016
Estimated completion	31 December 2016
Sites	1 location across United States

Drugs / interventions tested

• Oxytocin (OXYTOCIN) — full drug profile →

Conditions studied

• Sleep Apnea — all drugs for Sleep Apnea →

Sponsor

George Washington University

Who can join

18 and older, any sex, with Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Hypopnea Events Primary · Duration of single overnight sleep study (variable)

Hypopnea events are defined as a reduction in ventilation of 30% that lasted for at least 10 s and resulted in a decrease in arterial saturation of 4% or more. The frequency of hypopnea events is the number of times these events took place during the overnight sleep study.

Group	Value	95% CI
Oxytocin	8.5	± 2.0

Frequency of Apnea Events Primary · Duration of the overnight sleep study (variable)

Apnea events are defined as instances of reduction in the peak signal excursion of 90% lasting at least 10 s. Frequency of apnea events is the incidence of these events during a single, over-night sleep study.

Group	Value	95% CI
Oxytocin	17.3	± 5.7

Sponsor's own description

In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease with high cardiovascular risk factors, yet this disease remains very poorly treated. This proposal, based on the current literature and new basic science results detailed above on the role of oxytocin in cardiovascular control, will test if oxytocin administration improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding to test this important hypotheses more thoroughly and in larger clinical trials.

This study will explore if intranasal oxytocin has any positive cardiovascular benefits in patients with sleep apnea.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.