Oxytocin on HR in Sleep Apnea Patient

• ClinicalTrials.gov Identifier: NCT02564068
• Recruitment Status: Enrolling by invitation
• First Posted: September 30, 2015
• Last Update Posted: February 9, 2022
• Sponsor: George Washington University
• Information provided by (Responsible Party): Vivek Jain, George Washington University

Study Description

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	Drug: Oxytocin; Drug: Placebo	Early Phase 1

Detailed Description:

Cohort A: 10 Subjects

10 subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (PSG) and have been diagnosed with OSA will be recruited into the research study to assess the beneficial effects of oxytocin treatment.

These 10 subjects will undergo another "in the sleep-lab" diagnostic polysomnography that is identical to the one that they had for standard of care to diagnose OSA. Within one hour prior to the research polysomnography the subjects will be given oxytocin (40 IU) intranasally. Outcome measures will be assessed.

Cohort B: 10 Subjects

Once enrollment in Cohort A is complete, then enrollment into Cohort B will begin.

10 Subjects that have recently undergone either a standard "in the sleep-lab" diagnostic polysomnography or an "at home" PSG test and have been diagnosed with OSA will be recruited into the research study where we will assess the beneficial effects of oxytocin treatment.

These 10 subjects will undergo an "in the sleep-lab" diagnostic polysomnography that would be identical to the one they had for standard of care medical guidelines if they were diagnosed with OSA "in the sleep-lab". This research polysomnography should be performed within 4 weeks of their OSA diagnosis PSG.

Subjects will be randomized by the Investigational Drug Services Pharmacy of the MFA to be administered either Oxytocin (40 IU) or placebo within one hour prior to beginning the study polysomnography. Subjects will then return within 4 weeks to have a second research study polysomnography performed by the sleep-lab. Subjects will be administered the intervention that they did not received during the first research PSG study within one hour prior to beginning the second polysomnography. Either Oxytocin (40 IU) or placebo. For example: If at study polysomnography 1 a subject is randomized to receive placebo 1 hour prior to the start of the polysomnography, then at study polysomnography 2 the subject will be administered oxytocin (40 IU) 1 hour prior to the start of the polysomnography. Outcome measures will be assessed.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 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: Treatment
• Official Title: Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
• Actual Study Start Date: May 22, 2015
• Estimated Primary Completion Date: May 22, 2022
• Estimated Study Completion Date: May 22, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oxytocin Only; Subjects will come in for one visit, and will receive only oxytocin	Drug: Oxytocin; 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. Ten 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.; Other Name: Synotocin
Experimental: Oxytocin & Placebo Crossover; Subjects will come in for two visit: They will receive either placebo or oxytocin on visit 1 and the other intervention of visit 2. Subjects will be blinded as to which drug they are receiving on which visit.	Drug: Oxytocin; 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. Ten 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.; Other Name: Synotocin; Drug: Placebo; Group B is a crossover study, where subjects will be randomized to receive either placebo or active drug on their first visit, and then the opposite intervention on their second visit.

Outcome Measures

Primary Outcome Measures :

1. Mean changes in heart rate with apneic and hypopneic events [ Time Frame: 3 years ]

Eligibility Criteria

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

Criteria

Inclusion 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 polysonmography (per standard of care medical guidelines), or the "at home" diagnostic test for cohort B, and have been diagnosed with OSA will be recruited into a follow-up study to assess the beneficial effects of oxytocin treatment.

Exclusion Criteria:

• Pregnant or nursing women or women at any child bearing age who are not willing to undergo . methods to prevent pregnancy

  • A female subject of childbearing potential is a nonmenopausal female who has not had a . hysterectomy, bilateral oopherectomy, or medically documented ovarian failure. Menopause . can be assumed to have occurred in a woman when there is either:

    1. Appropriate medical documentation of prior complete bilateral oophorectomy OR
    2. Permanent cessation of previously occurring menses as a result of ovarian failure with . documentation of hormonal deficiency. Ovarian hormonal deficiency is documented by . serum follicle stimulating hormone (FSH) level elevated to within the post-menopausal . . range based on the laboratory reference range where the hormonal assay is performed.
    3. Menopause is defined as occurring 12 months after your last menstrual period and marks the . end of menstrual cycles
• Subjects who are on medications that affect cardiac autonomic function (eg. Beta blockers)
• Smokers
• Subjects who are unable to read or answer questions in the English language

Contacts and Locations

Locations

United States, District of Columbia

GW-Medical Faculty Associates

Washington, District of Columbia, United States, 20036

Sponsors and Collaborators

George Washington University

Investigators

• Principal Investigator: Vivek Jain, MD; The George Washington University

More Information

• Responsible Party: Vivek Jain, Principal Investigator, George Washington University
• ClinicalTrials.gov Identifier: NCT02564068
• Other Study ID Numbers: GWU_IRB_41333
• First Posted: September 30, 2015
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD is not currently planned to be shared with other researchers

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

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs