Clinical trial NCT03148899: Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
Official title: Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea
Oxytocin Nasal Spray
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Duration of Obstructive Events
timeFrame: Assessed on Visit 1- Day 1, Visit 2- Day 29
Secondary outcomes:
measure: Respiratory Rate
timeFrame: Assessed on Visit 1- Day 1, Visit 2- Day 29
measure: Incidence Proportion of Bradycardia
timeFrame: Assessed on Visit 1- Day 1, Visit 2- Day 29
measure: O2 Minimum
timeFrame: Assessed on Visit 1- Day 1, Visit 2- Day 29
Other outcomes:
Locations:
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Vivek Jain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Washington University
name: David Mendelowitz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jain V, Kimbro S, Kowalik G, Milojevic I, Maritza Dowling N, Hunley AL, Hauser K, Andrade DC, Del Rio R, Kay MW, Mendelowitz D. Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study. Sleep Med. 2020 Oct;74:242-247. doi: 10.1016/j.sleep.2020.05.034. Epub 2020 Jun 5.