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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

NCTNCT03148899 (opens ClinicalTrials.gov in a new tab)Other idGWU_IRB_041333
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
32 participants (actual)
Sponsor
George Washington University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
27 Jul 2016
Primary completion
7 Jun 2020
Completion
7 Jun 2020
First posted
11 May 2017
Last update posted
31 Jan 2023
Conditions
Sleep Apnea, Obstructive

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018201920202021
  1. Ph 2

    Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep

    NCT03148899

    27 Jul 2016 to 7 Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oxytocin Intranasal SprayDrug
  • Placebo Intranasal SprayDrug

Arms2

  • Experimental

    Visit 1 Randomization

    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.

  • Experimental

    Visit 2: Crossover Randomization

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Duration of Obstructive Events

    Time frame · Assessed on Visit 1- Day 1, Visit 2- Day 29

Secondary outcomes(3)

  1. Respiratory Rate

    Time frame · Assessed on Visit 1- Day 1, Visit 2- Day 29

  2. Incidence Proportion of Bradycardia

    Time frame · Assessed on Visit 1- Day 1, Visit 2- Day 29

    Registry description

    Event-associated bradycardias were identified as a heart rate reduction of 5 bpm or more from the average heart rate during the 5 s preceding an event to the lowest heart rate either during an event or within 5 s immediately after an event. Incidence proportion, or risk, of bradycardia was calculated as follows: the number of events that resulted in bradycardia divided by the total number of events. This analysis was done using custom MATLAB (MathWorks) code to study heart rate and peripheral capillary oxyhemoglobin saturation (SPO2) before and after apnea and hypopnea events.

  3. O2 Minimum

    Time frame · Assessed on Visit 1- Day 1, Visit 2- Day 29

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Assessed on Visit 1- Day 1, Visit 2- Day 29

Duration of Obstructive Events

GroupValue (seconds)Spread
Oxytocin22.724.59
Placebo24.665.12
Secondary and other outcome results(3)
Secondary outcomeMean· Assessed on Visit 1- Day 1, Visit 2- Day 29

Respiratory Rate

GroupValue (breaths per minute)Spread
Oxytocin17.393.50
Placebo16.693.24
Secondary outcomeMean· Assessed on Visit 1- Day 1, Visit 2- Day 29

Incidence Proportion of Bradycardia

GroupValue (proportion of events)Spread
Oxytocin0.080.07
Placebo0.140.07
Secondary outcomeMean· Assessed on Visit 1- Day 1, Visit 2- Day 29

O2 Minimum

GroupValue (% of Oxygen Saturation)Spread
Oxytocin94.311.80
Placebo92.444.24

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinAt 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. Oxytocin Intranasal Spray: 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. Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.0 / 320 / 320 / 32
PlaceboAt 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. Oxytocin Intranasal Spray: 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. Placebo Intranasal Spray: The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.0 / 320 / 320 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

6 results

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.

Jain et al. 2020Sleep medicinecited by 31

PMID 32862007DOI 10.1016/j.sleep.2020.05.034PUB-32862007

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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