Oxytocin on HR in Sleep Apnea Patient

NCT ID: NCT02564068

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-22
• Study Completion Date: 2016-12-31

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

Cohort A: 8 Subjects

8 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 8 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.

These 8 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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

These 8 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".

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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. 8 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.

Oxytocin

These 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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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. 8 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.

Interventions

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. 8 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.

Intervention Type: DRUG

Other Intervention Names

Synotocin

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Vivek Jain

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vivek Jain, MD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Locations

GW-Medical Faculty Associates

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

GWU_IRB_41333

Identifier Type: -

Identifier Source: org_study_id