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Combination Therapy to Treat Sleep Apnea

NCT01633827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-03-03

Study results available
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Summary

In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep. This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an increased risk for developing high blood pressure. Currently, the best treatment for obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose (i.e. Continuous positive airway pressure \[CPAP\] treatment). While CPAP treatment stops the upper airway from closing in most people, many people have difficulty sleeping with the mask in place and therefore do not use the CPAP treatment. This research study is being conducted to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will improve OSA severity by altering some of the traits that are responsible for the disorder.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DRUG

Placebo pill

Subjects will receive a sugar pill (in combination with room air) during their placebo arm studies

DRUG

Sedative

Subjects will receive eszopiclone (in combination with medical oxygen) during their treatment arm studies

OTHER

Room air

Subjects will receive room air (in combination with a sugar pill) during their placebo arm studies

OTHER

Oxygen

Subjects will receive medical grade oxygen (in combination with eszopiclone) during their treatment arm studies

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • David A Wellman, MD · Brigham & Womens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633827 on ClinicalTrials.gov