Oxytocin for Sleep Apnea

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

Trial Summary

What is the purpose of this trial?

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 Positive Airway Pressure (CPAP) device while sleeping decreasing some of the harmful effects of low oxygen in people with sleep apnea. This study will last 35 nights and involves spending three nights in the sleep lab at George Washington University. There are no additional costs to participants and no compensation for being involved in the study.

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.

What evidence supports the effectiveness of the drug oxytocin for sleep apnea?

Research shows that oxytocin, when given through the nose, can help reduce the number and length of breathing interruptions in people with sleep apnea. It may work by stimulating muscles in the tongue to keep the airway open during sleep. ^{1 2 3 4 5}

Is oxytocin safe for use in humans?

Oxytocin, used in various forms like Syntocinon, has been generally safe in humans, with no side effects observed in a large study of obstetrical patients. In studies for autism, common side effects included nasal discomfort and tiredness, but these were not significantly linked to oxytocin use. Rare severe reactions like aggression and seizures were reported, but more research is needed to confirm safety in different populations. ^{3 6 7 8 9}

How does the drug oxytocin work differently for sleep apnea?

Oxytocin is unique for sleep apnea because it is administered intranasally (through the nose) and works by stimulating tongue muscles to keep the airway open, reducing the duration and frequency of breathing interruptions during sleep. ^{1 2 5 7 10}

Research Team

Vivek Jain, MD

Principal Investigator

George Washington University

David Mendelowitz, PhD

Principal Investigator

George Washington University

Eligibility Criteria

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 have been diagnosed with a sleep disorder.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

Synthetic oxytocin. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The influence of oxytocin-based interventions on sleep-wake and sleep-related behaviour and neurobiology: A systematic review of preclinical and clinical studies. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Oxytocin mediated excitation of hypoglossal motoneurons: implications for treating obstructive sleep apnea. [2023]

6. Australia pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Anaphylactoid reaction to oxytocin in pregnancy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Oxytocin neuron activation prevents hypertension that occurs with chronic intermittent hypoxia/hypercapnia in rats. [2022]