Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: George Washington University
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant or Breastfeeding women

• Women of Child Bearing Potential who are not willing to undergo methods to prevent pregnancy

• Subjects who are on medications that affect cardiac autonomic function (eg. Beta Blockers)

• Active smokers

• Subjects who are unable to read or answer questions in the English language