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Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

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ClinicalTrials.gov Identifier: NCT03148899
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Vivek Jain, George Washington University

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Drug: Oxytocin Intranasal Spray Drug: Placebo Intranasal Spray Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All members of the research team except the IP dispensing staff will be blinded for the duration of the research study. Once all the subjects have finished in the research study, and all data is data-locked, the outcomes assessor will then unblind the research data for the statistical analysis.
Primary Purpose: Other
Official Title: Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
Actual Study Start Date : July 27, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Visit 1 Randomization
At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
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.
Other Name: Synotocin

Drug: Placebo Intranasal Spray
The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
Other Name: Placebo

Experimental: Visit 2: Crossover Randomization
At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving.
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.
Other Name: Synotocin

Drug: Placebo Intranasal Spray
The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
Other Name: Placebo




Primary Outcome Measures :
  1. Mean changes in heart rate with apneic and hypopneic events [ Time Frame: 3 years ]
    Heart rate will be monitored during the study


Secondary Outcome Measures :
  1. Apnea-Hypopnea Index [ Time Frame: 1 years ]
    Apnea-Hypopnea Index will be monitored during the study

  2. Percentage of time spent by the patients in certain oxygen saturations [ Time Frame: 1 year ]
    Oxygen saturation classifications include: > 90%, > 80% but < 90%, and < 80%

  3. Length of Apnea and Hypopnea Events & AHI Index [ Time Frame: 1 year ]
    This and all data will be gathered from the PSG report.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148899


Contacts
Contact: Fiona J Dore, BS 202-741-2342 fdore@mfa.gwu.edu

Locations
United States, District of Columbia
The GW Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Fiona J Dore, BS    202-741-2342    fdore@mfa.gwu.edu   
Principal Investigator: Vivek Jain, MD         
Principal Investigator: David Mendelowitz, PhD         
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Vivek Jain, MD The George Washington University
Principal Investigator: David Mendelowitz The George Washington University

Responsible Party: Vivek Jain, Principle Investigator, George Washington University
ClinicalTrials.gov Identifier: NCT03148899     History of Changes
Other Study ID Numbers: GWU_IRB_041333
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time there is no plan to share IPD

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vivek Jain, George Washington University:
Sleep Apnea
Oxytocin Nasal Spray

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs