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

ConditionsSleep ApneaSleep Apnea, Obstructive
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVivek Jain

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women 18 years of age or older.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Oxytocin

    Drug

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

  • Placebo

    Drug

    Intranasal spray to mimic Oxytocin intranasal spray

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Visit 1 RandomizationExperimental treatment 2 interventions
Group B: Visit 2 Crossover RandomizationExperimental treatment 2 interventions

Trial outcomes

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

Time frame
5 weeks

Secondary outcomes

1

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

Sleep satisfaction will be self-recorded on Epworth Sleepiness Scale (ESS). Range from 0 equal to lowest sleepiness during day and 24 equal to highest sleepiness during day.

Time frame
5 weeks
2

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

Range is from 0-21 with 0 equal to better sleep quality and 21 meaning worst sleep quality.

Time frame
5 weeks
3

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

Sleep quality will be recorded from range 5 to 30 total score, 5 equal to worst sleep quality and 30 equal to best sleep quality.

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vivek Jain

Lead sponsor

George Washington University

Sponsor institution

George Washington University

Collaborator

Source ClinicalTrials.gov
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