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Completed

NCT Number: NCT02564068

Oxytocin on HR in Sleep Apnea Patient

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

GW-Medical Faculty Associates

Washington D.C., District of Columbia, 20036, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Appropriate medical documentation of prior complete bilateral oophorectomy OR
  • 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.
  • 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

Treatment and study plan

Oxytocin

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.

Other names: Synotocin

Primary outcomes

  1. Frequency of Hypopnea Events

    Time frame: Duration of single overnight sleep study (variable)

    Hypopnea events are defined as a reduction in ventilation of 30% that lasted for at least 10 s and resulted in a decrease in arterial saturation of 4% or more. The frequency of hypopnea events is the number of times these events took place during the overnight sleep study.

  2. Frequency of Apnea Events

    Time frame: Duration of the overnight sleep study (variable)

    Apnea events are defined as instances of reduction in the peak signal excursion of 90% lasting at least 10 s. Frequency of apnea events is the incidence of these events during a single, over-night sleep study.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2015
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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