Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine

NCT03860233 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GWU_IRB_031857
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea; Sleep Apnea, Obstructive

Keywords

Continuous Positive Airway Pressure; CPAP; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Use of oxytocin will change pressure required to keep open airway during auto-CPAP use

  CPAP pressures will be monitored during study via electronic data retrieval system

  5 weeks

Secondary Outcomes (3)

• Change in total score of self-reported daytime sleepiness using Epworth Sleepiness Scale

  5 weeks

• Change in total score of self-reported sleep quality on Pittsburgh Quality Index

  5 weeks

• Change in total score for sleep quality with Post Polysomnogram Sleep Assessment

  5 weeks

Study Arms (2)

Visit 1 Randomization

EXPERIMENTAL

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.

Drug: Oxytocin; Drug: Placebo

Visit 2 Crossover Randomization

EXPERIMENTAL

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.

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

40 IU administered intranasal, within 1 hour prior to sleeping for 14 days

Visit 1 Randomization; Visit 2 Crossover Randomization

Placebo DRUG

Intranasal spray to mimic Oxytocin intranasal spray

Also known as: Placebo (for Oxytocin)

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 of age or older.

You may not qualify if:

• subjects not willing to or otherwise unable to use CPAP for treatment of OSA.
• Presence of other sleep disorders
• Pregnant or breastfeeding women
• Women of child-bearing age (WOCBA) not willing or unable to use an accepted method to avoid pregnancy for the entire duration of the study
• Prisoners or subjects who are involuntarily incarcerated
• Subjects who are compulsorily detain or treatment of either a psychiatric or physical (i.e. infectious disease) illness
• Patients unable to give consent because of a language barrier, or other reason.

Sponsors & Collaborators

• Vivek Jain: lead
• George Washington University: collaborator

Study Sites (1)

Medical Faculty Associates

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

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Vivek Jain, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

• David Mendelowitz, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivek Jain, MD

CONTACT

202-741-2237; vjain@mfa.gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All study staff are masked except the pharmacist.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: March 1, 2019
• Study Start: March 4, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)