Primary outcomeMean· Duration of single overnight sleep study (variable)
Frequency of Hypopnea Events
| Group | Value (Incidence of hypopnea events) | Spread |
|---|---|---|
| Oxytocin | 8.5 | 2.0 |
Trial · Interventional
CompletedEarly phase 1Results postedRegistry dataOxytocin on HR in Sleep Apnea Patient
NCTNCT02564068 (opens ClinicalTrials.gov in a new tab)Other idGWU_IRB_41333
Overview
- Status
- Completed
- Phase
- Early phase 1
- Enrollment
- 8 participants (actual)
- Sponsor
- George Washington University · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 22 May 2015
- Primary completion
- 31 Dec 2016
- Completion
- 31 Dec 2016
- First posted
- 30 Sept 2015 (estimated)
- Last update posted
- 27 Nov 2023
- Conditions
- Sleep Apnea
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201520162017
- Ph Early 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
Arms2
Experimental
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".
Experimental
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.
Primary outcomes2
Outcomes the sponsor listed as primary.
Frequency of Hypopnea Events
Time frame · Duration of single overnight sleep study (variable)
Registry description
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.
Frequency of Apnea Events
Time frame · Duration of the overnight sleep study (variable)
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Duration of the overnight sleep study (variable)
Frequency of Apnea Events
| Group | Value (Incidence of apnea events) | Spread |
|---|---|---|
| Oxytocin | 17.3 | 5.7 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oxytocin OnlySubjects will come in for one visit, and will receive only oxytocin 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. | – | 0 / 8 | 0 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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