Early Phase 1
N=8
Oxytocin on HR in Sleep Apnea Patient
Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02564068 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Frequency of Hypopnea Events — 8.5 Incidence of hypopnea events
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Oxytocin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- George Washington University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Hypopnea Events |
8.5 | — |
| PRIMARY Frequency of Apnea Events |
17.3 | — |
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.
Eligibility 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:
- 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
Data sourced from ClinicalTrials.gov (NCT02564068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.