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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Vivek Jain
Study ID
NCT03860233
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxytocin — DRUG
    40 IU administered intranasal, within 1 hour prior to sleeping for 14 days
  • Placebo — DRUG
    Intranasal spray to mimic Oxytocin intranasal spray

Study Details

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.

Key Dates

Start date
Mar 4, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Visit 1 Randomization
    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.
  • Experimental: Visit 2 Crossover Randomization
    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.

Primary Outcome Measure

Use of oxytocin will change pressure required to keep open airway during auto-CPAP use [ Time Frame: 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical Faculty AssociatesWashington D.C.District of Columbia20037
Vivek Jain, MD
[email protected]
202-741-2237
David Mendelowitz, PhD
202-994-3466

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Medical Faculty Associates· Washington D.C., DC

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