CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 8 enrolled
Drug / intervention
Oxytocindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02564068
NCT02564068Early Ph 1Completed

Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

George Washington University·interventional·Posted Sep 30, 2015·Updated Nov 27, 2023

In Brief

A Early Phase 1 clinical trial evaluating Oxytocin for Sleep Apnea. Completed, enrolled 8 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 30, 2015
Enrollment StartMay 22, 2015
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

Oxytocindrug

To test that intranasal oxytocin administration blunts the deleterious hypoxia/hypercapnia induced changes in heart rate that occur during nocturnal apnea in patients with OSA, we will examine the changes in heart rate in a group of patients that have recently been diagnosed with OSA. 8 subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines, and not for research purposes) and have been diagnosed with OSA will be recruited into a study to assess the beneficial effects of oxytocin treatment.