Sleep Apnea, ObstructivePhase 2NCT03148899
Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
A Phase 2 study testing Oxytocin Intranasal Spray in people with Sleep Apnea, Obstructive, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Oxytocin Intranasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2016to 7 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 18 years old or older of any ethnic background
- Subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines), or the "at home" diagnostic test, and have been diagnosed with OSA
Who cannot join
- Pregnant or Breastfeeding women
- Women of Child Bearing Potential who are not willing to undergo methods to prevent pregnancy
- Subjects who are on medications that affect cardiac autonomic function (eg. Beta Blockers)
- Active smokers
- Subjects who are unable to read or answer questions in the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
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.
Read the detailed description
Obstructive Sleep Apnea (OSA) is a major, yet poorly understood cardiovascular health risk that occurs in as many as 24% of males and 9% of females within the US population. OSA can participate in both the initiation and progression of several cardiovascular diseases including sudden death, hypertension, arrhythmias, myocardial ischemia and stroke.
Many of the adverse cardiovascular consequences of OSA are thought to be associated with a diminished cardiac vagal activity, as parasympathetic cardiac vagal activity is typically cardio-protective. Intranasal administration of oxytocin has been shown to significantly increase parasympathetic and decrease sympathetic cardiac control. In this research study, the effect oxytocin has on changes in heart rate or other Polysomnography (PSG) measures in a group of patients that have recently been diagnosed with OSA will be examined.
OSA is typically diagnosed through a polysomnography, a comprehensive recording of the biophysiological changes that occur during sleep. The PSG monitors many body functions including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation (EMG) and heart rhythm (ECG) during sleep, respiratory airflow, respiratory effort, pulse oximetry etc.
In this research study, subjects who have recently been diagnosed with OSA will undergo two research study PSGs. Before the first study PSG, subjects will be randomized to receive either Oxytocin (40 IU) or placebo, in a blinded manner, prior to beginning the test. The PSG will then continue as usual, and subject data pertaining to the PSG will be gathered. Subjects will then return within 4 weeks for a second research PSG, where one hour before the test they will receive the opposite intervention that they did not received during the first research PSG study. Data measurements will be re-measured and compared between the two PSGs.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Oxytocin Intranasal Spray, Placebo Intranasal Spray
- Keywords
- Sleep Apnea, Oxytocin Nasal Spray
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin Intranasal SprayDrug
Also called Synotocin
In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
Placebo Intranasal SprayDrug
Also called Placebo
The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
| Study group | Role | What they receive |
|---|---|---|
| Visit 1 Randomization | Experimental | At visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving. Receives: Drug: Oxytocin Intranasal Spray; Drug: Placebo Intranasal Spray |
| Visit 2: Crossover Randomization | Experimental | At visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving. Receives: Drug: Oxytocin Intranasal Spray; Drug: Placebo Intranasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Obstructive Events
Measured: Assessed on Visit 1- Day 1, Visit 2- Day 29
Secondary outcomes (3)
Respiratory Rate
Measured: Assessed on Visit 1- Day 1, Visit 2- Day 29
Incidence Proportion of Bradycardia
Event-associated bradycardias were identified as a heart rate reduction of 5 bpm or more from the average heart rate during the 5 s preceding an event to the lowest heart rate either during an event or within 5 s immediately after an event.
Incidence proportion, or risk, of bradycardia was calculated as follows: the number of events that resulted in bradycardia divided by the total number of events.
This analysis was done using custom MATLAB (MathWorks) code to study heart rate and peripheral capillary oxyhemoglobin saturation (SPO2) before and after apnea and hypopnea events.
Measured: Assessed on Visit 1- Day 1, Visit 2- Day 29
O2 Minimum
Measured: Assessed on Visit 1- Day 1, Visit 2- Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start27 Jul 2016
- Primary completion7 Jun 2020
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivek Jain, George Washington University
- Investigators
- Vivek Jain, MD, Principal investigator, The George Washington UniversityDavid Mendelowitz, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148899
- Sponsor's protocol ID
- GWU_IRB_041333
- Status last verified
- Jan 2023
- First submitted
- 30 Mar 2017
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to share IPD
Publications
Jain V, Kimbro S, Kowalik G, Milojevic I, Maritza Dowling N, Hunley AL, Hauser K, Andrade DC, Del Rio R, Kay MW, Mendelowitz D. Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study. Sleep Med. 2020 Oct;74:242-247. doi: 10.1016/j.sleep.2020.05.034. Epub 2020 Jun 5.
PubMed 32862007
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
- ClinicalTrials.gov ID
- NCT03148899
- Acronym / sponsor ID
- GWU_IRB_041333
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Oxytocin Nasal Spray
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 31 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Obstructive Sleep Apnea (OSA) is a major, yet poorly understood cardiovascular health risk that occurs in as many as 24% of males and 9% of females within the US population. OSA can participate in both the initiation and progression of several cardiovascular diseases including sudden death, hypertension, arrhythmias, myocardial ischemia and stroke.
Many of the adverse cardiovascular consequences of OSA are thought to be associated with a diminished cardiac vagal activity, as parasympathetic cardiac vagal activity is typically cardio-protective. Intranasal administration of oxytocin has been shown to significantly increase parasympathetic and decrease sympathetic cardiac control. In this research study, the effect oxytocin has on changes in heart rate or other Polysomnography (PSG) measures in a group of patients that have recently been diagnosed with OSA will be examined.
OSA is typically diagnosed through a polysomnography, a comprehensive recording of the biophysiological changes that occur during sleep. The PSG monitors many body functions including brain (EEG), eye movements (EOG), muscle activity or skeletal muscle activation (EMG) and heart rhythm (ECG) during sleep, respiratory airflow, respiratory effort, pulse oximetry etc.
In this research study, subjects who have recently been diagnosed with OSA will undergo two research study PSGs. Before the first study PSG, subjects will be randomized to receive either Oxytocin (40 IU) or placebo, in a blinded manner, prior to beginning the test. The PSG will then continue as usual, and subject data pertaining to the PSG will be gathered. Subjects will then return within 4 weeks for a second research PSG, where one hour before the test they will receive the opposite intervention that they did not received during the first research PSG study. Data measurements will be re-measured and compared between the two PSGs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visit 1 Randomization | Experimental | Drug: Oxytocin Intranasal Spray, Drug: Placebo Intranasal SprayAt visit 1 (PSG 1) subjects will receive one of two interventions: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving. |
| Visit 2: Crossover Randomization | Experimental | Drug: Oxytocin Intranasal Spray, Drug: Placebo Intranasal SprayAt visit 2 (PSG 2) subjects will receive the opposite intervention from the one they received at visit 1: either Oxytocin Intranasal Spray (40 IU) or Placebo Intranasal Spray. Subjects will be blinded as to which drug they are receiving. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women 18 years old or older of any ethnic background
- Subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysomnography (per standard of care medical guidelines), or the "at home" diagnostic test, and have been diagnosed with OSA
Key exclusion criteria (5 listed)
- Pregnant or Breastfeeding women
- Women of Child Bearing Potential who are not willing to undergo methods to prevent pregnancy
- Subjects who are on medications that affect cardiac autonomic function (eg. Beta Blockers)
- Active smokers
- Subjects who are unable to read or answer questions in the English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin Intranasal SprayAlso: SynotocinIn human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress. | Drug | Visit 1 Randomization, Visit 2: Crossover Randomization |
| Placebo Intranasal SprayAlso: PlaceboThe placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray. | Drug | Visit 1 Randomization, Visit 2: Crossover Randomization |
Primary outcome
Duration of Obstructive Events
Time frame: Assessed on Visit 1- Day 1, Visit 2- Day 29
3 secondary outcomes
Respiratory Rate
Time frame: Assessed on Visit 1- Day 1, Visit 2- Day 29
Incidence Proportion of Bradycardia
Time frame: Assessed on Visit 1- Day 1, Visit 2- Day 29
O2 Minimum
Time frame: Assessed on Visit 1- Day 1, Visit 2- Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32862007Jain V, Kimbro S, Kowalik G, Milojevic I, Maritza Dowling N, Hunley AL, Hauser K, Andrade DC, Del Rio R, Kay MW, Mendelowitz D. Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study. Sleep Med. 2020 Oct;74:242-247. doi: 10.1016/j.sleep.2020.05.034. Epub 2020 Jun 5.
- Individual participant dataSharing planned: No. At this time there is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Jain, MD principal investigator
The George Washington University
David Mendelowitz principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin Intranasal Spray in people with Sleep Apnea, Obstructive, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Obstructive Events (time frame: Assessed on Visit 1- Day 1, Visit 2- Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.