Oxytocin for Sleep Apnea

Recruiting at 1 trial location

Overseen By Vivek Jain, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vivek Jain

Disqualifiers: Other sleep disorders, Pregnancy, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an oxytocin nose spray can assist people with sleep apnea by reducing the pressure needed from a CPAP machine, potentially lessening the negative effects of low oxygen during sleep. Participants will use either the oxytocin spray or a placebo (a treatment that mimics the real one) without knowing which they receive, and then switch after a period. It is designed for those who use a CPAP machine but still experience sleep apnea issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oxytocin affects sleep and breathing. Some studies found that when administered as a nasal spray, oxytocin may help people with sleep apnea, a condition where breathing repeatedly stops and starts during sleep. Importantly, oxytocin is generally well-tolerated.

Previous research has linked oxytocin to better sleep and breathing patterns. Animal studies suggest that oxytocin might help control breathing. While these findings are promising, human studies are ongoing to determine oxytocin's safety and effectiveness for treating sleep apnea.

Regarding side effects, oxytocin is usually safe when used as directed. However, monitoring for any negative effects during clinical trials is important. Participants in this study will receive either oxytocin or a placebo to assess the treatment's impact on sleep apnea.

Overall, oxytocin shows promise as a potential treatment for sleep apnea, but more research is needed to confirm its safety and effectiveness for this specific use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sleep apnea?

Oxytocin is unique because it offers a novel approach to treating sleep apnea by potentially leveraging its natural role in social bonding and relaxation to improve sleep quality. Unlike traditional treatments like CPAP machines or oral appliances, which mechanically keep airways open, oxytocin may address the condition by influencing brain pathways that regulate sleep and breathing. Researchers are excited about this treatment because it introduces a non-invasive, intranasal delivery method that could offer a more comfortable and user-friendly alternative for patients struggling with existing therapies.

What evidence suggests that oxytocin might be an effective treatment for sleep apnea?

Research has shown that oxytocin might help with sleep apnea by shortening pauses in breathing and reducing shallow breathing. Studies have found that oxytocin use shortens the duration of these breathing problems. This trial will test oxytocin as one of the interventions, with participants receiving either oxytocin or a placebo. Oxytocin might improve breathing during sleep and seems to help control breathing, which could explain its benefits for people with sleep apnea. Overall, early evidence suggests that oxytocin could be helpful for those with sleep apnea. ^{2 3 4 6 7}

Who Is on the Research Team?

Vivek Jain, MD

Principal Investigator

George Washington University

David Mendelowitz, PhD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with obstructive sleep apnea who use a CPAP machine. It's not for those unwilling to use CPAP, with other sleep disorders, pregnant or breastfeeding women, or if they can't consent due to language barriers.

Exclusion Criteria

Prisoners or subjects who are involuntarily incarcerated

I am unable or unwilling to use CPAP for sleep apnea.

I have been diagnosed with a sleep disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Phase 1

Participants receive either oxytocin nasal spray or placebo for 2 weeks, followed by a sleep study and blood collection

2 weeks

1 overnight in-lab sleep study

Washout

Participants undergo a 1-week washout period while continuing standard CPAP use

1 week

Treatment Phase 2

Participants receive the opposite treatment (oxytocin or placebo) for 2 weeks, followed by a sleep study and blood collection

2 weeks

1 overnight in-lab sleep study

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin
• Placebo

Trial Overview The study tests whether oxytocin nasal spray can reduce the pressure needed from a CPAP machine in sleep apnea patients. Participants will spend three nights in a lab at George Washington University over 35 days.

How Is the Trial Designed?

Group I: Visit 2 Crossover Randomization Experimental Treatment 2 Interventions

At visit 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.

Group II: Visit 1 Randomization Experimental Treatment 2 Interventions

At visit 1subjects 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.

Oxytocin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Who Is Running the Clinical Trial?

Vivek Jain

Lead Sponsor

Trials

1

Recruited

40+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Published Research Related to This Trial

Syntocinon(R), a synthetic form of oxytocin, was found to be as effective as natural oxytocin in a study involving 3,342 obstetrical patients.

The use of Syntocinon(R) showed no significant side effects, such as vasospasm or anaphylactic reactions, suggesting it is safe for clinical use in obstetrics when properly indicated and monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin. HIBBARD, LT., ANDREWS, AV.[2018]

A systematic review of five randomized controlled trials involving 223 participants found that long-term use of intranasal oxytocin in treating autism spectrum disorder (ASD) is generally well tolerated, with common side effects like nasal discomfort and tiredness not significantly linked to the treatment.

While some severe adverse events were reported, such as aggression and seizures, the overall safety profile suggests that intranasal oxytocin is safe for use in the ASD population, warranting further research to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Cai, Q., Feng, L., Yap, KZ.[2018]

A study involving 95 generally healthy older men found that chronic intranasal oxytocin (OT) administration for 4 weeks was safe and well-tolerated, with no significant adverse effects on cardiovascular or metabolic health.

The incidence and severity of adverse events were low and similar between the OT and placebo groups, suggesting that OT does not increase the risk of side effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial. Rung, JM., Horta, M., Tammi, EM., et al.[2023]

Oxytocin is widely used to augment labor in low-risk first-time mothers, with a survey indicating that 38% of such labors in the UK are treated with intravenous syntocinon.

There is significant variation in the dosing and administration of syntocinon across Scottish obstetric units, which raises concerns about potential risks to both mothers and fetuses due to misuse, highlighting the need for standardized guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in oxytocin regimes in Scottish labour wards in 1998. Arnott, N., Harrold, AJ., Lynch, P.[2004]

Carbetocin is as effective as syntometrine in preventing primary postpartum hemorrhage, with no significant difference in hemoglobin drop or the need for additional oxytocic injections among 329 women studied.

Carbetocin has a lower incidence of adverse effects such as nausea, vomiting, and hypertension compared to syntometrine, making it a safer alternative for managing the third stage of labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. Leung, SW., Ng, PS., Wong, WY., et al.[2021]

A case study highlights an allergic reaction to Syntocinon, a synthetic form of oxytocin, during a Caesarean section, indicating potential safety concerns with its use.

This incident underscores the importance of monitoring for allergic reactions when administering Syntocinon in surgical settings, even though it is commonly used to aid in uterine contraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactoid reaction to oxytocin in pregnancy. Slater, RM., Bowles, BJ., Pumphrey, RS.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28798255/

Benefits of oxytocin administration in obstructive sleep apnea Both apneas and hypopneas were significantly shortened in duration with oxytocin treatment. Oxytocin treatment significantly decreased the percent of apnea and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03860233

Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) ... This study will investigate if an intra-nasal nose spray of the drug oxytocin can decrease the amount of pressure needed from the automatic Continuous ...

3. academic.oup.com academic.oup.com/jes/article/9/1/bvae198/7908926

Oxytocin Receptor Polymorphism Is Associated With Sleep ... Oxytocin supplementation improves obstructive sleep apnea (OSA), and animal studies suggest involvement of oxytocin in respiratory control.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763421004589

The influence of oxytocin-based interventions on sleep ... Oxytocin (OXT) interventions can influence sleep-wake behaviour and neurobiology. Preclinically, OXT system activation exerts wake-promoting effects at higher ...

5. journals.physiology.org journals.physiology.org/doi/abs/10.1152/ajplung.00206.2017

Benefits of oxytocin administration in obstructive sleep apnea Both apneas and hypopneas were significantly shortened in duration with oxytocin treatment. Oxytocin treatment significantly decreased the percent of apnea and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8874508/

Overview of the Role of Pharmacological Management of ... Outcomes measured were sleep apnea severity, perceived nasal congestion, sleep quality, and oxygenation during sleep. However, results showed that although ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02564068

NCT02564068 | Oxytocin on HR in Sleep Apnea Patient This study will explore if intranasal oxytocin has any positive cardiovascular benefits in patients with sleep apnea.