Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

Sleep Apnea, Obstructive Clinical Trial

Official title:

Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148899
• Other study ID #: GWU_IRB_041333
• Status: Completed
• Phase: Phase 2
• Start date: July 27, 2016
• Est. completion date: June 7, 2020

Study information

• Verified date: January 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Obstructive Sleep Apnea (OSA) is a major, yet poorly understood cardiovascular health risk that occurs in as many as 24% of males and 9% of females within the US population. OSA can participate in both the initiation and progression of several cardiovascular diseases including sudden death, hypertension, arrhythmias, myocardial ischemia and stroke.

Many of the adverse cardiovascular consequences of OSA are thought to be associated with a diminished cardiac vagal activity, as parasympathetic cardiac vagal activity is typically cardio-protective. Intranasal administration of oxytocin has been shown to significantly increase parasympathetic and decrease sympathetic cardiac control. 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. Before the first study PSG, subjects will be randomized to receive either Oxytocin (40 IU) or placebo, in a blinded manner, prior to beginning the test. The PSG will then continue as usual, and subject data pertaining to the PSG will be gathered. Subjects will then return within 4 weeks for a second research PSG, where one hour before the test they will receive the opposite intervention that they did not received during the first research PSG study. Data measurements will be re-measured and compared between the two PSGs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 7, 2020
• Est. primary completion date: June 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Oxytocin Intranasal Spray
In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
• Placebo Intranasal Spray
The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.

Locations

Country	Name	City	State
United States	The GW Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Obstructive Events		Assessed on Visit 1- Day 1, Visit 2- Day 29
Secondary	Respiratory Rate		Assessed on Visit 1- Day 1, Visit 2- Day 29
Secondary	Incidence Proportion of Bradycardia	Event-associated bradycardias were identified as a heart rate reduction of 5 bpm or more from the average heart rate during the 5 s preceding an event to the lowest heart rate either during an event or within 5 s immediately after an event.; Incidence proportion, or risk, of bradycardia was calculated as follows: the number of events that resulted in bradycardia divided by the total number of events.; This analysis was done using custom MATLAB (MathWorks) code to study heart rate and peripheral capillary oxyhemoglobin saturation (SPO2) before and after apnea and hypopnea events.	Assessed on Visit 1- Day 1, Visit 2- Day 29
Secondary	O2 Minimum		Assessed on Visit 1- Day 1, Visit 2- Day 29