Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

NCT03148899 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GWU_IRB_041333
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea; Oxytocin Nasal Spray

Outcome Measures

Primary Outcomes (1)

• Duration of Obstructive Events

  Assessed on Visit 1- Day 1, Visit 2- Day 29

Secondary Outcomes (3)

• Respiratory Rate

  Assessed on Visit 1- Day 1, Visit 2- Day 29

• Incidence Proportion of Bradycardia

  Assessed on Visit 1- Day 1, Visit 2- Day 29

• O2 Minimum

  Assessed on Visit 1- Day 1, Visit 2- Day 29

Study Arms (2)

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.

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.

Drug: Oxytocin Intranasal Spray; Drug: Placebo Intranasal Spray

Interventions

Oxytocin Intranasal Spray DRUG

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.

Also known as: Synotocin

Visit 1 Randomization; Visit 2: Crossover Randomization

Placebo Intranasal Spray DRUG

The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.

Also known as: Placebo

Visit 1 Randomization; Visit 2: Crossover Randomization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• 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.

  PMID: 32862007 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Vivek Jain
• Organization: Medical Faculty Associates at The George Washington University

vjain@mfa.gwu.edu

202-741-2676

Study Officials

• Vivek Jain, MD

  The George Washington University

  PRINCIPAL INVESTIGATOR

• David Mendelowitz

  The George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All members of the research team except the IP dispensing staff will be blinded for the duration of the research study. Once all the subjects have finished in the research study, and all data is data-locked, the outcomes assessor will then unblind the research data for the statistical analysis.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: May 11, 2017
• Study Start: July 27, 2016
• Primary Completion: June 7, 2020
• Study Completion: June 7, 2020
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)